[go: up one dir, main page]

WO2025184589A1 - Compositions contenant des sels pharmaceutiquement acceptables et d'autres dérivés d'agonistes du récepteur du peptide-1 de type glucagon et leurs utilisations - Google Patents

Compositions contenant des sels pharmaceutiquement acceptables et d'autres dérivés d'agonistes du récepteur du peptide-1 de type glucagon et leurs utilisations

Info

Publication number
WO2025184589A1
WO2025184589A1 PCT/US2025/017967 US2025017967W WO2025184589A1 WO 2025184589 A1 WO2025184589 A1 WO 2025184589A1 US 2025017967 W US2025017967 W US 2025017967W WO 2025184589 A1 WO2025184589 A1 WO 2025184589A1
Authority
WO
WIPO (PCT)
Prior art keywords
semaglutide
anion
molar ratio
compound
cationic component
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/017967
Other languages
English (en)
Inventor
Tyler Brown
Kelly IBSEN
Kevin Henry
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
I2O Therapeutics Inc
Original Assignee
I2O Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by I2O Therapeutics Inc filed Critical I2O Therapeutics Inc
Publication of WO2025184589A1 publication Critical patent/WO2025184589A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/542—Carboxylic acids, e.g. a fatty acid or an amino acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C219/00—Compounds containing amino and esterified hydroxy groups bound to the same carbon skeleton
    • C07C219/02—Compounds containing amino and esterified hydroxy groups bound to the same carbon skeleton having esterified hydroxy groups and amino groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C219/04—Compounds containing amino and esterified hydroxy groups bound to the same carbon skeleton having esterified hydroxy groups and amino groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C219/06—Compounds containing amino and esterified hydroxy groups bound to the same carbon skeleton having esterified hydroxy groups and amino groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having the hydroxy groups esterified by carboxylic acids having the esterifying carboxyl groups bound to hydrogen atoms or to acyclic carbon atoms of an acyclic saturated carbon skeleton
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C229/00—Compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C229/02—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C229/04—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C229/06—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton
    • C07C229/10—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings
    • C07C229/12—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having only one amino and one carboxyl group bound to the carbon skeleton the nitrogen atom of the amino group being further bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings to carbon atoms of acyclic carbon skeletons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons

Definitions

  • Glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide
  • GLP-1 receptor agonists are used for the treatment of various diseases or conditions, such as metabolic diseases, and for weight management.
  • GLP-1 receptor agonists such as semaglutide
  • GLP-1 receptor agonists such as semaglutide
  • the anion of semaglutide derives from the structure of the compound in Table 2.
  • the cationic component is selected from the group consisting of alkali metal, alkaline earth metal, a metal ion such as aluminum, sodium, lithium, potassium, magnesium, calcium, and zinc, ammonium (NH4 + ), a protonated or positively (+) charged ion from an aliphatic primary amine, secondary amine or tertiary amine such as 2-aminoethanol, tromethamine, dimethylamine, diethylamine, N-ethyl-glucamine, hydrabamine, trimethylamine, triethylamine, dicyclohexylamine, ethanolamine, diethanolamine, triethanolamine, dimethylethanolamine, (2,2′,2′′-nitrilotris(ethanol)),
  • the cationic component is WSGR Docket No.: 56017-729.601 not choline.
  • the cationic component comprises the structure of: [0008]
  • the cationic component is selected from the group consisting of alkali metal, alkaline earth metal, a metal ion, ammonium (NH4 + ), a protonated or positively (+) charged ion from an aliphatic primary amine, secondary amine or tertiary amine , aralkyl amine, benzathine, benethamine; heterocyclic aromatic amine, quaternary ammonium, nontoxic quaternary ammonium, 1H-imidazole, substituted-imidazole, pyrrolidine, substituted pyrrolidine, piperidine or substituted piperidine, piperazine or substituted piperazine, morpholine, substituted morpholine, basic amino acid, aminoguanidine, guanidine derivatives, and an amine cation formed using a counterion.
  • a metal ion comprises aluminum, sodium, lithium, potassium, magnesium, calcium, or zinc
  • the aliphatic primary amine, secondary amine, or tertiary amine comprises 2-aminoethanol, tromethamine, dimethylamine, diethylamine, N-ethyl-glucamine, hydrabamine, trimethylamine, triethylamine, dicyclohexylamine, ethanolamine, diethanolamine, triethanolamine, dimethylethanolamine, (2,2′,2′′-nitrilotris(ethanol)), 2-diethylaminoethanol, procaine or substituted procaine, meglumine, carnitine, ethylenediamine, choline, or acetylcholine;
  • aralkyl amine comprises ⁇ , ⁇ -dibenzylethylenediamine;
  • heterocyclic aromatic amine comprises pyridine, pyrimidine, picoline, quino
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7, or any ratio between any two of these values.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:7.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7, or any ratio between any two of these values.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraph, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4.
  • the cationic component is selected from the group of cationic components listed in Table 3.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7, or any ratio between any two of these values.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a weight % (wt. %) ratio relative to the anion of semaglutide as listed in Table 3.
  • the quaternary ammonium has the structure of wherein: R 8 , R 9 , R 10 , and R 11 are each independently a substituted or unsubstituted group selected from C1- 6 aliphatic, phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • the quaternary ammonium has the structure of wherein: R 8 , R 9 , R 10 , and R 11 are each independently a substituted or unsubstituted C1-6 aliphatic. [0018] In some embodiments, the quaternary ammonium has the structure of wherein: (i) R 8 , R 9 , R 10 , and R 11 are independently C 1 -C 6 alkyl; (ii) R 8 , R 9 , R 10 , and R 11 are independently C1-C4 alkyl; WSGR Docket No.: 56017-729.601 (iii) R 8 , R 9 , and R 10 are C2 alkyl; and R 11 is C1 alkyl; (iv) R 8 , R 9 , and R 10 are C 4 alkyl; and R 11 is C 1 alkyl; (v) all of R 8 , R 9 , R 10 , and R 11 are C1 alkyl; (vi)
  • the cationic component is a quaternary ammonium, wherein the anion of semaglutide and quaternary ammonium are provided in a molar ratio of anion of semaglutide to quaternary ammonium that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7, or any ratio between any two of these values.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and quaternary ammonium are provided in a molar ratio of anion of semaglutide to quaternary ammonium that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7, or any ratio between any two of these values.
  • the quaternary ammonium has the structure of or .
  • the quaternary ammonium has the structure of .
  • the cationic component is a quaternary ammonium having the structure , , wherein the anion of semaglutide and quaternary ammonium are provided in a molar ratio of anion of semaglutide to quaternary ammonium that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7, or any ratio between any two of these values.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1 :2, 1:3, 1:4, 1:5, 1:6, and 1:7.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4.
  • a molar ratio of : is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7.
  • a molar ratio of : is selected from the group consisting of about 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7. [0027] In some embodiments, a molar ratio of : is about 1:4. [0028] In some embodiments, provided is a hydrate of the compound of the structure of Formula I.
  • the term “hydrate”, as used herein, means a solid or a semi-solid form of a chemical compound containing water in a molecular complex. The water is generally in a stoichiometric amount with respect to the chemical compound. Exemplary hydrates include (compound of Formula I • ZH2O), wherein Z is from 1 to 50 equivalents of H2O.
  • a compound comprising the structure of Formula IIa, Formula IIb, Formula IIc, or any combination thereof: Formula IIa, Formula IIb, Formula IIc, WSGR Docket No.: 56017-729.601 any combination thereof is one or more cations of semaglutide; and anionic component.
  • a compound consisting, or consisting essentially, of the structure of Formula IIa, Formula IIb, Formula IIc, or any combination thereof is provided herein.
  • the one or more cations of semaglutide derive from the structure of the compound in Table 2.
  • the anionic component is selected from the group consisting of besylate, mesylate, tosylate, sulfonate, sulfate, methylsulfate, camsylate, isethionate, edisylate, 1- hydroxy-2-naphthoate, 2,2-dichloroacetate, 2-hydroxyethanesulfonate, 2-oxoglutarate, 4- acetamidobenzoate, 4-aminosalicylate, acetate, adipate, ascorbate, aspartate, benzenesulfonate, benzoate, bromide, chloride, camphorate, camphor-10-sulfonate, caprate (decanoate), caproate (hexanoate), caprylate (octanoate), carbonate, cinnamate, citrate, cyclamate, dodecylsulfate, dodecylsulfurate, ethan
  • the anionic component is betaine. In some embodiments, the anionic component comprises the structure . In some embodiments, the anionic component has the structure of: . [0034] In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:1, 1:2, 1:3, or 1:4, or any ratio between any two of these values. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:4.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4.
  • the anionic component is selected from the group of anionic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is about 1:1, 1:2, 1:3, or 1:4, or any ratio between any two of these values.
  • the anionic component is selected from the group of anionic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from about 1:1 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from about 1:2 to about 1:4. In some embodiments, the anionic component is selected from the group of cationic components listed in Table 4.
  • the WSGR Docket No.: 56017-729.601 anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is about 1:1, 1:2, 1:3, or 1:4, or any ratio between any two of these values.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from about 1:1 to about 1:4.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from about 1:2 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a weight % (wt. %) ratio relative to the one or more cations of semaglutide as listed in Table 4. [0035] In some embodiments, the anionic component is selected from the group consisting of those in Table 4. [0036] In some embodiments, any of the anionic components of Table 4 is provided in any of the molar ratios and weight ratios of Table 4 relative to one or more cations of semaglutide.
  • the anionic component and cation of semaglutide are provided in a molar ratio of cation of semaglutide to anionic component that is selected from the group consisting of about 1:1, 1:2, 1:3, and 1:4.
  • the anionic component and cation of semaglutide are provided in a molar ratio of cation of semaglutide to anionic component that is selected from the group consisting of about 1:2, 1:3, and 1:4.
  • the anionic component and cation of semaglutide are provided in a molar ratio of cation of semaglutide to anionic component that is about 1:3.
  • the anionic component and cation of semaglutide are provided in a molar ratio of cation of semaglutide to anionic component that is about 1:4.
  • a molar ratio of any combination thereof is selected from the group consisting of about 1:1, 1:2, 1:3, and 1:4.
  • a molar ratio of , , , or any WSGR Docket No.: 56017-729.601 combination thereof: is selected from the group consisting of about 1:2, 1:3, and 1:4.
  • a molar ratio of , , or any combination thereof: is about 1:4.
  • a molar ratio of , , , or any combination thereof: is about 1:3.
  • a hydrate of the compound of the structure of Formula I Exemplary hydrates include (compound of Formula IIa, Formula IIb, Formula IIc, or any combination thereof • ZH2O), wherein Z is from 1 to 50.
  • a weight % (wt. %) ratio of , , or any combination thereof is from about 0.1 wt. %: 99.9 wt. % to about 20.0 wt. %: 80.0 wt. %.
  • a molar ratio of : is from about 2:1 to about 10:1; or (ii) a molar ratio of , or any combination thereof is from about 2:1 to about 10:1.
  • WSGR Docket No.: 56017-729.601 [0048] In some embodiments, (i) a molar ratio of : is from about 2:1 to about 7:1; or (ii) a molar ratio any combination thereof is from about 2:1 to about 7:1.
  • a molar ratio of : is from about 3:1 to about 7:1; or (ii) a molar ratio of , or any combination thereof is from about 3:1 to about 7:1.
  • a molar ratio of : is from about 4:1 to about 7:1; or (ii) a molar ratio any combination thereof is from about 4:1 to about 7:1.
  • a molar ratio of : is from about 3:1 to about 7:1; or (ii) a molar ratio of , or any combination thereof is about 4:1.
  • WSGR Docket No.: 56017-729.601 (i) a molar ratio of : is from about 3:1 to about 7:1; or (ii) a molar ratio of , , or any combination thereof is about 4:1.
  • a compound comprising the structure of Formula IIIa: Formula IIIa, or a pharmaceutically acceptable salt thereof, wherein: is a covalent derivative of one or more carboxyl groups of semaglutide, or a pharmaceutically acceptable salt thereof; and each R 100 is as defined herein.
  • R 100 is methyl, ethyl, n-propyl, iso-propyl, n-butyl, iso-butyl, tert- butyl, or pentyl, fluoromethyl, difluoromethyl, trifluoromethyl, CHCH3OC(O)OCH2CH, -CH3, - CH 2 CH 3 , -CH(CH 3 ) 2 , CH 2 CH 2 CH 2 CH 3 , C(CH 3 ) 3 , -CH 2 CH 2 N(CH 3 ) 3+, substituted C 1 - 6 aliphatic, unsubstituted C1-6 aliphatic, substituted (C1-22)alkyl, unsubstituted (C1-22)alkyl, substituted (C1- 22)alkenyl, unsubstituted (C1-22)alkenyl, substituted phenyl, unsubstituted phenyl, substituted - C(O)R, un
  • the compound of Formula IIIa does not have the structure of Formula II, wherein R 8 , R 9 , and R 10 are independently C1-C5 alkyl.
  • R 8 , R 9 , and R 10 are independently C1-C5 alkyl.
  • a compound comprising the structure of Formula IIIb: Formula IIIb or a pharmaceutically acceptable salt thereof; wherein: is a covalent derivative of one or more hydroxyl groups of semaglutide, or a pharmaceutically acceptable salt thereof; and each R 101 is as defined herein.
  • R 101 is selected from the group consisting of -CH2R, -C(O)R, - C(O)OR, -C(O)N(R)2, -OP(O)OROR, wherein each occurrence of R is independently hydrogen or an optionally substituted group selected from C1-6 aliphatic, a 3-8 membered saturated or partially unsaturated monocyclic carbocyclic ring, phenyl, an 8-10 membered bicyclic aromatic WSGR Docket No.: 56017-729.601 carbocyclic ring, a 4-8 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, and sulfur, a 5-6 membered monocyclic heteroaromatic ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur, and an 8-10 membered bicyclic heteroaromatic ring having 1-5 heteroatoms independently selected from nitrogen, oxygen, and sulfur; or [0058]
  • R 101 is the unsubstituted C(O)C1-6alkyl comprising COCH3, COCH2CH3, or COCH(CH3)2), or R 101 is the substituted C(O)C1-6alkyl comprising COCF3, COCHCF2, or -COCH2CF.
  • R 101 is -C(O)R selected from the group consisting of -C(O)CH3 and -C(O)H, -C(O)OR that is -C(O)OH2), -C(O)N(R)2 selected from the group consisting of - C(O)NH2 and -C(O)N(CH3)2), or -OP(O)OROR that is -OP(O)OHOH.
  • R 101 is -CHCH3OC(O)OCH2CH3.
  • a compound comprising the structure of Formula IIIc and/or Formula IIId: Formula IIIc Formula IIId or a pharmaceutically acceptable salt of each thereof; wherein: WSGR Docket No.: 56017-729.601 is each a covalent derivative of one or more amino or imidazole groups of semaglutide, or a pharmaceutically acceptable salt thereof; and each of R 102 and R 103 is as defined herein.
  • each of R 102 and R 103 is independently selected from the group consisting of -CH2R, -C(O)R, -C(O)OR, -C(O)N(R)2, -OP(O)OROR, wherein each occurrence of R is independently hydrogen or an optionally substituted group selected from C1-6 aliphatic, a 3-8 membered saturated or partially unsaturated monocyclic carbocyclic ring, phenyl, an 8-10 membered bicyclic aromatic carbocyclic ring, a 4-8 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, and sulfur, a 5-6 membered monocyclic heteroaromatic ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur, and an 8-10 membered bicyclic heteroaromatic ring having 1-5 heteroatoms independently selected from nitrogen, oxygen, and sulfur; each R 102 and R 103 is independently C(O)
  • each R 102 and R 103 is independently -CH2OCH2CH2OH or unsubstituted C(O)C1-6alkyl.
  • R 102 is substituted C(O)C1-6alkyl comprising COCF3, COCHCF2, or -COCH2CF.
  • R 102 is substituted C(O)phenyl or unsubstituted C(O)phenyl.
  • R 102 is CHCH3OC(O)OCH2CH3.
  • the term “pharmaceutically acceptable salt” refers to any of the cationic components or anionic components described herein.
  • a pharmaceutical composition comprising the WSGR Docket No.: 56017-729.601 compound as provided herein, and a pharmaceutically acceptable excipient.
  • the pharmaceutical composition is formulated for parenteral administration, oral administration, or implantable administration.
  • the pharmaceutical composition is formulated for subcutaneous administration or intravenous administration.
  • a drug delivery device comprising the compound as provided herein or the pharmaceutical composition as provided herein.
  • the drug delivery device is a syringe, a single-dose pen with an injection needle, or an autoinjector with an injection needle.
  • the drug delivery device is an implantable osmotic drug delivery device.
  • a kit comprising the compound as provided herein, the pharmaceutical composition as provided herein, or the drug delivery device as provided herein.
  • the kit as provided herein further comprises an instruction for use.
  • a method of treating a disease or disorder in a subject in need thereof comprising administering to the subject a therapeutically effective amount of the compound as provided herein, or the pharmaceutical composition as provided herein, wherein the administering is effective to treat the disease or disorder in the subject.
  • provided herein is the compound as provided herein or the pharmaceutical composition as provided herein for use in a method of treating a disease or disorder in a subject in need thereof by administering to the subject a therapeutically effective amount of the compound as provided herein, or the pharmaceutical composition as provided herein, wherein the administering is effective to treat the disease or disorder in the subject.
  • the administering is effective to treat the disease or disorder in the subject.
  • the compound or the pharmaceutical composition is administered to the subject using the drug delivery device as provided herein.
  • the disease or disorder is a metabolic disease or disorder, a cardiovascular disease or disorder, chronic kidney disease, or a neurological disease or disorder.
  • the disease or disorder is selected from the group consisting of type 1 diabetes, type 2 diabetes, obesity, overweight, metabolic dysfunction–associated fatty liver WSGR Docket No.: 56017-729.601 disease (MAFLD), metabolic dysfunction-associated steatohepatitis (MASH), and nonalcoholic steatohepatitis (NASH).
  • the disease or disorder is selected from the group consisting of arrhythmia, coronary artery disease, heart failure, valve disease, aortic disease, congenital heart disease, heart attack, angina, cardiomyopathy, peripheral arterial disease, atherosclerosis, cardiac dysrhythmias, pericarditis, pulmonary hypertension, stroke, cerebrovascular disease, rheumatic heart disease, atrial fibrillation, Brugada syndrome, aortic stenosis, bradycardia, endocarditis, high cholesterol, and long QT syndrome.
  • the disease or disorder is Parkinson’s disease or Alzheimer disease.
  • the subject is human.
  • the compound or the pharmaceutical composition is administered to the subject via parenteral administration, oral administration, or implantable administration. [0087] In some embodiments, the compound or the pharmaceutical composition is administered to the subject via subcutaneous administration or intravenous administration. [0088] In another aspect, provided herein is a method of reducing weight in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the compound as provided herein or the pharmaceutical composition as provided herein, wherein the administering is effective to reduce weight in the subject.
  • provided herein is the compound as provided herein or the pharmaceutical composition as provided herein for use in a method of reducing weight in a subject in need thereof by administering to the subject a therapeutically effective amount of the compound as provided herein or the pharmaceutical composition as provided herein, wherein the administering is effective to reduce weight in the subject.
  • the administering is effective to reduce weight in the subject.
  • the compound or the pharmaceutical composition is administered to the subject using the drug delivery device as provided herein.
  • the subject is human.
  • the subject has obesity or is overweight.
  • the compound or the pharmaceutical composition is administered to the subject via parenteral administration, oral administration, or implantable administration.
  • WSGR Docket No.: 56017-729.601 In some embodiments, the compound or the pharmaceutical composition is administered to the subject via subcutaneous administration or intravenous administration.
  • FIG.2A shows a photograph of a representative clear solution (C) of an exemplary salt of semaglutide in water
  • FIG. 2B shows a photograph of a representative solution of semaglutide free acid (i.e., base form) having visible precipitation (P) in water, both of which were obtained from Example 8.
  • FIG. 3A, FIG. 3B and FIG. 3C show the solubility of various exemplary salts of semaglutide at high and low temperature for extended periods, as shown by the data obtained in Example 9: solubility studies of various exemplary salts of semaglutide.
  • FIG. 3A, FIG. 3B and FIG. 3C show the solubility of various exemplary salts of semaglutide at high and low temperature for extended periods, as shown by the data obtained in Example 9: solubility studies of various exemplary salts of semaglutide.
  • FIG. 3A demonstrates that an exemplary salt of semaglutide, the choline-semaglutide salt, exhibited improved solubility in both water (right graph) and DMSO (left graph) at low and high temperatures over 40 days.
  • FIG. 3B demonstrates that another exemplary salt of semaglutide, the sodium-semaglutide salt, was insoluble in DMSO at low temperature, e.g., at 4 ⁇ C, and had reproducibly intermittent solubility in water at elevated temperatures, e.g., at 37 ⁇ C.
  • FIG. 4 shows data from thioflavin T fluorescence aggregation studies as described in Example 10, comparing the propensity of aggregation of semaglutide free acid (i.e., base form), and exemplary salts of semaglutide, i.e., the choline-semaglutide salt and the sodium-semaglutide salt, as aqueous solutions at 1 mg/mL and 5 mg/mL.
  • FIG. 4 shows data from thioflavin T fluorescence aggregation studies as described in Example 10, comparing the propensity of aggregation of semaglutide free acid (i.e., base form), and exemplary salts of semaglutide, i.e., the choline-semaglutide salt and the sodium-semaglutide salt, as aqueous solutions at 1 mg/mL and 5 mg/mL.
  • semaglutide is in a cationic form and the counterion is an anion. In some embodiments, semaglutide is in an anionic form and the counterion is a cation. In some embodiments, the compound is a salt composed of an ionic form of semaglutide and a counterion WSGR Docket No.: 56017-729.601 thereof. In some embodiments, semaglutide is a cationic component of the salt and the counterion is an anionic component of the salt. In some embodiments, semaglutide is an anionic component of the salt and the counterion is a cationic component of the salt.
  • Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP- 1 hormone that is released in the gastrointestinal tract in response to eating.
  • GLP-1s glucagon-like peptide-1
  • One role of GLP-1s, such as semaglutide, is to prompt the body to produce more insulin, which reduces blood glucose (sugar).
  • Semaglutide has an amino acid sequence similar to human GLP-1, augmented by several improvements in chemical structure that render semaglutide a far superior therapeutic and more “drug-like” than endogenous GLP-1.
  • the first six amino acids of GLP-1 are missing from the amino acid sequence of semaglutide.
  • Substitutions are made at GLP-1 positions 8 and 34 (semaglutide positions 2 and 28) such that alanine and lysine are replaced by 2-aminoisobuteric acid and arginine, respectively.
  • the former substitution deters breakdown by endogenous enzymes including dipeptidyl peptidase-IV, and thus enhances metabolic stability of semaglutide relative to GLP-1.
  • Semaglutide is further modified at the lysine of position 20 by covalent attachment of a long C18 lipophilic side chain ending with a carboxylate group that increases semaglutide’s binding affinity to blood protein (albumin), which significantly prolongs the presence of this peptide in blood circulation. Consequently, semaglutide's elimination half-life (t1/2) from blood is about seven days (165–184 hours) vs human GLP-1’s t1/2 of several minutes which renders semaglutide amenable to weekly subcutaneous injection. Semaglutide comprises seven ionizable carboxylate groups, inclusive of the carboxylate group described above.
  • Ozempic ⁇ and Wegovy ⁇ injections and the Rybelsus ⁇ tablets are all formulated as the “free acid” with respect to the ionizable carboxylate groups of semaglutide.
  • Applicant has discovered that semaglutide, despite being optimized for “drug-likeness” WSGR Docket No.: 56017-729.601 with respect to its amino acid sequence and chemical structure, is nonetheless unoptimized for drug-likeness with respect to potential ionic salt, ester and/or prodrug forms of this peptide.
  • % semaglutide, or molar ratio of any given salt to semaglutide peptide can be used to further “tune” certain desired drug like properties of this peptide relative to those of the unoptimized free acid of semaglutide.
  • Applicant conducted comparative experimentation and analyses of the resulting data to identify certain ionic salt forms, esters and prodrugs of semaglutide, in certain wt. % ratios of salt to semaglutide, generally ranging from 0.1 wt. % to 50.0 wt. % salt relative to 99.9 wt. % to 50.0 wt.
  • % semaglutide or in certain molar ratios from 1:1 to 100:1 of salt, ester and/or prodrug to semaglutide, that provide surprising advantages including enhanced stability and improved solubility in an aqueous environment relative to known injectable and oral administrations of the free acid of semaglutide.
  • improved pharmaceutical compositions comprising disclosed salt forms of semaglutide, and in some embodiments having wt. % ratios of salt to semaglutide from 0.1 wt. % to 50.0 wt. % salt relative to 99.9 wt. % to 50.0 wt.
  • improved pharmaceutical compositions comprising disclosed salt forms of semaglutide of the present invention may permit lower dosing (and reduced cost of goods, i.e., COGs) as an additional means to achieve greater efficacy than existing “free acid” formulations of semaglutide.
  • polypeptide “peptide” and “protein” (if single chain) are used interchangeably herein to refer to polymers of amino acids of any length.
  • the polymer may be linear or branched, it may comprise modified amino acids, and it may be interrupted by non-amino acids.
  • the terms also encompass an amino acid polymer that has been modified; for example, disulfide bond formation, glycosylation, lipidation, acetylation, phosphorylation, or any other manipulation, such as conjugation with a labeling component.
  • the polypeptide can be isolated from natural sources, can be a produced by recombinant techniques from a eukaryotic or prokaryotic host, or can be a product of synthetic procedures.
  • the terms “nucleic acid,” “nucleic acid sequence,” “nucleotide sequence,” or “polynucleotide sequence,” and “polynucleotide” are used interchangeably. As used herein, they refer to a polymeric form of nucleotides of any length, either deoxyribonucleotides or WSGR Docket No.: 56017-729.601 ribonucleotides, or analogs thereof.
  • the polynucleotide may be either single-stranded or double- stranded, and if single-stranded may be the coding strand or non-coding (antisense) strand.
  • a polynucleotide may comprise modified nucleotides, such as methylated nucleotides and nucleotide analogs. The sequence of nucleotides may be interrupted by non-nucleotide components.
  • a polynucleotide may be further modified after polymerization, such as by conjugation with a labeling component.
  • the nucleic acid may be a recombinant polynucleotide, or a polynucleotide of genomic, cDNA, semisynthetic, or synthetic origin which either does not occur in nature or is linked to another polynucleotide in a non-natural arrangement.
  • the compositions and methods as provided herein encompass polypeptides and nucleic acids having the sequences specified, or sequences substantially identical or similar thereto, e.g., sequences at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%.
  • the term “substantially identical” is used herein to refer to a first amino acid that contains a sufficient or minimum number of amino acid residues that are i) identical to, or ii) conservative substitutions of aligned amino acid residues in a second amino acid sequence such that the first and second amino acid sequences can have a common structural domain and/or common functional activity.
  • amino acid sequences that contain a common structural domain having at least about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%.97%, 98%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, 99.9%, or 100% sequence identity to a reference sequence, e.g., a sequence provided herein.
  • nucleotide sequence in the context of nucleotide sequence, the term “substantially identical” is used herein to refer to a first nucleic acid sequence that contains a sufficient or minimum number of nucleotides that are identical to aligned nucleotides in a second nucleic acid sequence such that the first and second nucleotide sequences encode a polypeptide having common functional activity, or encode a common structural polypeptide domain or a common functional polypeptide activity.
  • nucleotide sequences having at least about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%.
  • the sequences are aligned for optimal comparison purposes (e.g., gaps can be introduced in one or both of a first and a second amino acid or nucleic acid sequence for optimal alignment and non-homologous sequences can be WSGR Docket No.: 56017-729.601 disregarded for comparison purposes).
  • the length of a reference sequence aligned for comparison purposes is at least 30%, preferably at least 40%, more preferably at least 50%, 60%, and even more preferably at least 70%, 80%, 90%, 100% of the length of the reference sequence.
  • the amino acid residues or nucleotides at corresponding amino acid positions or nucleotide positions are then compared.
  • amino acid or nucleic acid “identity” is equivalent to amino acid or nucleic acid “homology”.
  • the percent identity between the two sequences is a function of the number of identical positions shared by the sequences, taking into account the number of gaps, and the length of each gap, which need to be introduced for optimal alignment of the two sequences.
  • the comparison of sequences and determination of percent identity between two sequences can be accomplished using a mathematical algorithm.
  • the percent identity between two amino acid sequences is determined using the Needleman and Wunsch ((1970) J. Mol. Biol.
  • the percent identity between two nucleotide sequences is determined using the GAP program in the GCG software package (available at http://www.gcg.com), using a NWSgapdna.CMP matrix and a gap weight of 40, 50, 60, 70, or 80 and a length weight of 1, 2, 3, 4, 5, or 6.
  • a particularly preferred set of parameters are a Blossum 62 scoring matrix with a gap penalty of 12, a gap extend penalty of 4, and a frameshift gap penalty of 5.
  • the percent identity between two amino acid or nucleotide sequences can be determined using the algorithm of E. Meyers and W. Miller ((1989) CABIOS, 4:11-17) which has been incorporated into the ALIGN program (version 2.0), using a PAM120 weight residue table, a gap length penalty of 12 and a gap penalty of 4.
  • the nucleic acid and protein sequences described herein can be used as a “query sequence” to perform a search against public databases to, for example, identify other family members or related sequences.
  • Such searches can be performed using the NBLAST and XBLAST programs (version 2.0) of Altschul, et al. (1990) J. Mol. Biol. 215:403-10.
  • Gapped BLAST can be utilized as described in Altschul et al., (1997) WSGR Docket No.: 56017-729.601 Nucleic Acids Res.
  • agonist refers to a molecule or an agent that activates a receptor to produce a biological response.
  • antagonist refers to a molecule or an agent that blocks the action of the agonist
  • inverse agonist refers to a molecule or an agent that causes an action opposite to that of the agonist.
  • the agonist may be an endogenous agonist.
  • the agonist may be an exogenous agonist.
  • the agonist may be a polypeptide.
  • the agonist may be a polynucleotide, a nucleoside, an amino acid, a sugar, a carbohydrate, a lipid, or any combination thereof.
  • the agonist may be a chemical.
  • the term “variant,” as used herein, refers to a polypeptide that has a substantially identical amino acid sequence to a reference amino acid sequence, or is encoded by a substantially identical nucleotide sequence.
  • the variant is a functional variant.
  • a GLP-1 receptor agonist variant can bind to GLP-1 receptor and activate the GLP- 1 receptor signaling.
  • the term “functional variant,” as used herein, refers to a polypeptide that has a substantially identical amino acid sequence to a reference amino acid sequence, or is encoded by a substantially identical nucleotide sequence, and is capable of having one or more activities of the reference amino acid sequence.
  • the term “functional fragment,” as used herein, refers to a polypeptide that has a partial amino acid sequence of a reference amino acid sequence, and is capable of having one or more activities of the reference amino acid sequence.
  • the functional fragment comprises at least about 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9% amino acid sequence of a reference amino acid sequence.
  • the functional fragment comprises an amino acid sequence that has at most 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid deletion from the reference amino acid sequence.
  • the functional fragment comprises an amino acid sequence that has at least 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 350, 400, 450, or 500 amino acids of the reference amino acid sequence.
  • amino acid is intended to embrace all molecules, whether natural or synthetic, which include both an amino functionality and an acid functionality and capable of being included in a polymer of naturally-occurring amino acids.
  • exemplary amino acids include naturally-occurring amino acids; analogs, derivatives and congeners thereof; amino acid analogs having variant side chains; and all stereoisomers of any of any of the foregoing.
  • amino acid includes both the D- or L- optical isomers and peptidomimetics.
  • a “conservative amino acid substitution,” as used herein, is one in which the amino acid residue is replaced with an amino acid residue having a similar side chain. Families of amino acid residues having similar side chains have been defined in the art.
  • amino acids with basic side chains e.g., lysine, arginine, histidine
  • acidic side chains e.g., aspartic acid, glutamic acid
  • uncharged polar side chains e.g., glycine, asparagine, glutamine, serine, threonine, tyrosine, cysteine
  • nonpolar side chains e.g., alanine, valine, leucine, isoleucine, proline, phenylalanine, methionine, tryptophan
  • beta-branched side chains e.g., threonine, valine, isoleucine
  • aromatic side chains e.g., tyrosine, phenylalanine, tryptophan, histidine
  • the term “molecule” as used in, e.g., agonist molecule, polypeptide molecule, or receptor molecule includes full-length, naturally-occurring molecules, as well as variants, e.g., functional variants (e.g., truncations, fragments, mutated (e.g., substantially similar sequences) or derivatized form thereof), so long as at least one function and/or activity of the unmodified (e.g., naturally-occurring) molecule remains.
  • salt and “salt form” as used interchangeably herein, refer to a compound comprising an ionic assembly of positively charged cationic components (also known as positive ions and cations) and negatively charged anionic components (also known as negative ions and anions).
  • the salt is a neutral compound with no net electric charge.
  • the cationic components and the anionic components are held together by electrostatic forces termed ionic bonds.
  • GLP-1 glycol-like peptide-1
  • GLP-1 refers to a 30- or 31-amino- acid-long peptide hormone deriving from the tissue-specific posttranslational processing of the proglucagon peptide.
  • GLP-1 includes any of the recombinant or naturally- occurring forms of GLP-1 or variants or homologs thereof that have or maintain the GLP-1 activity (e.g., at least 40% 50%, 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, 99% or 100% activity).
  • the variants or homologs have at least 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%.
  • GLP-1 is substantially identical to the protein identified by the UniProt reference number P01275 or a variant or homolog having substantial identity thereto.
  • glucose-like peptide-1 (GLP-1) receptor refers to a G protein-coupled receptor found on cells and involved in the control of blood sugar level via regulation of insulin secretion.
  • the GLP-1 receptor is involved in the control of blood sugar level by enhancing the insulin secretion.
  • the GLP- 1 receptor is expressed on beta cells of the pancreas.
  • the GLP-1 receptor is expressed on neurons of the brain.
  • the GLP-1 receptor includes any of the recombinant or naturally-occurring forms of the GLP-1 receptor or variants or homologs thereof that have or maintain the GLP-1 receptor activity (e.g., at least 40% 50%, 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, 99% or 100% activity).
  • the variants or homologs have at least 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%.
  • GLP-1 receptor agonist refers to a molecule or an agent that activates the GLP-1 receptor to produce a biological response.
  • the GLP-1 receptor agonist induced regulation of the insulin secretion via activation of the GLP-1 receptor, thereby, leading to control of blood sugar level. In some embodiments, the GLP-1 receptor agonist induced enhancing the insulin secretion via activation of the GLP-1 receptor, thereby, leading to control of blood sugar level. In some embodiments, the GLP-1 receptor agonist mimics the GLP- 1 hormone, which is released in the gastrointestinal tract in response to eating. In some embodiments, the GLP-1 receptor agonist prompts the body to produce more insulin, which reduces the blood glucose.
  • the GLP-1 receptor agonist for example, in higher concentrations, promotes interaction with the parts of the brain that reduce appetite and signal a feeling of satiety or fullness.
  • the GLP-1 receptor agonist may be an endogenous agonist.
  • the GLP-1 receptor agonist may be an exogenous agonist.
  • the GLP-1 receptor agonist may be a polypeptide.
  • the GLP-1 receptor agonist may be a polynucleotide, a nucleoside, an amino acid, WSGR Docket No.: 56017-729.601 a sugar, a carbohydrate, a lipid, or any combination thereof.
  • the GLP-1 receptor agonist may be a small molecule.
  • Compounds and Salts of the present invention include those described generally herein. As used herein, the following definitions shall apply unless otherwise indicated. For purposes of this invention, the chemical elements are identified in accordance with the Periodic Table of the Elements, CAS version, Handbook of Chemistry and Physics, 75 th Ed. Additionally, general principles of organic chemistry are described in “Organic Chemistry”, Thomas Sorrell, University Science Books, Sausalito: 1999, and “March’s Advanced Organic Chemistry”, 5 th Ed., Ed.: Smith, M.B. and March, J., John Wiley & Sons, New York: 2001, the entire contents of which are hereby incorporated by reference.
  • aliphatic or “aliphatic group”, as used herein, means a straight-chain (i.e., unbranched) or branched, substituted or unsubstituted hydrocarbon chain that is completely saturated or that contains one or more units of unsaturation, or a monocyclic hydrocarbon or bicyclic hydrocarbon that is completely saturated or that contains one or more units of unsaturation, but which is not aromatic (also referred to herein as "carbocycle,” “cycloaliphatic” or “cycloalkyl”), that has a single point of attachment to the rest of the molecule.
  • aliphatic groups contain 1-6 aliphatic carbon atoms.
  • aliphatic groups contain 1-5 aliphatic carbon atoms. In other embodiments, aliphatic groups contain 1-4 aliphatic carbon atoms. In still other embodiments, aliphatic groups contain 1-3 aliphatic carbon atoms, and in yet other embodiments, aliphatic groups contain 1-2 aliphatic carbon atoms.
  • “cycloaliphatic” (or “carbocycle” or “cycloalkyl”) refers to a monocyclic C3-C6 hydrocarbon that is completely saturated or that contains one or more units of unsaturation, but which is not aromatic, that has a single point of attachment to the rest of the molecule.
  • Suitable aliphatic groups include, but are not limited to, linear or branched, substituted or unsubstituted alkyl, alkenyl, alkynyl groups and hybrids thereof such as (cycloalkyl)alkyl, (cycloalkenyl)alkyl or (cycloalkyl)alkenyl.
  • the term “lower alkyl” refers to a C1-4 straight or branched alkyl group.
  • Exemplary lower alkyl groups are methyl, ethyl, propyl, isopropyl, butyl, isobutyl, and tert-butyl.
  • lower haloalkyl refers to a C1-4 straight or branched alkyl group that is substituted with one or more halogen atoms.
  • heteroatom means one or more of oxygen, sulfur, nitrogen, phosphorus, or silicon (including, any oxidized form of nitrogen, sulfur, phosphorus, or silicon; the quaternized form of any basic nitrogen or; a substitutable nitrogen of a heterocyclic ring, for example N (as in WSGR Docket No.: 56017-729.601 3,4-dihydro-2H-pyrrolyl), NH (as in pyrrolidinyl) or NR + (as in N-substituted pyrrolidinyl)).
  • the term "unsaturated,” as used herein, means that a moiety has one or more units of unsaturation.
  • the term “bivalent C1-8 (or C1-6) saturated or unsaturated, straight or branched, hydrocarbon chain”, refers to bivalent alkylene, alkenylene, and alkynylene chains that are straight or branched as defined herein.
  • the term “cyclopropylenyl” refers to a bivalent cyclopropyl group of the following structure: .
  • halogen means F, Cl, Br, or I.
  • aryl used alone or as part of a larger moiety as in “aralkyl,” “aralkoxy,” or “aryloxyalkyl,” refers to monocyclic or bicyclic ring systems having a total of five to fourteen ring members, wherein at least one ring in the system is aromatic and wherein each ring in the system contains 3 to 7 ring members.
  • aryl may be used interchangeably with the term “aryl ring.”
  • aryl refers to an aromatic ring system which includes, but not limited to, phenyl, biphenyl, naphthyl, anthracyl and the like, which may bear one or more substituents.
  • aryl is a group in which an aromatic ring is fused to one or more non–aromatic rings, such as indanyl, phthalimidyl, naphthimidyl, phenanthridinyl, or tetrahydronaphthyl, and the like.
  • heteroaryl and “heteroar—,” used alone or as part of a larger moiety, e.g., “heteroaralkyl,” or “heteroaralkoxy,” refer to groups having 5 to 10 ring atoms, preferably 5, 6, or 9 ring atoms; having 6, 10, or 14 ⁇ electrons shared in a cyclic array; and having, in addition to carbon atoms, from one to five heteroatoms.
  • heteroatom refers to nitrogen, oxygen, or sulfur, and includes any oxidized form of nitrogen or sulfur, and any quaternized form of a basic nitrogen.
  • Heteroaryl groups include, without limitation, thienyl, furanyl, pyrrolyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, oxazolyl, isoxazolyl, oxadiazolyl, thiazolyl, isothiazolyl, thiadiazolyl, pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, indolizinyl, purinyl, naphthyridinyl, and pteridinyl.
  • heteroaryl and “heteroar—”, as used herein, also include groups in which a heteroaromatic ring is fused to one or more aryl, cycloaliphatic, or heterocyclyl rings, where the radical or point of attachment is on the heteroaromatic ring.
  • Nonlimiting examples include indolyl, isoindolyl, benzothienyl, benzofuranyl, dibenzofuranyl, indazolyl, benzimidazolyl, benzthiazolyl, quinolyl, isoquinolyl, cinnolinyl, phthalazinyl, quinazolinyl, quinoxalinyl, 4H–quinolizinyl, carbazolyl, acridinyl, phenazinyl, phenothiazinyl, phenoxazinyl, tetrahydroquinolinyl, tetrahydroisoquinolinyl, and pyrido[2,3–b]–1,4–oxazin–3(4H)–one.
  • heteroaryl group may be mono– or bicyclic.
  • heteroaryl may be used interchangeably with the terms “heteroaryl WSGR Docket No.: 56017-729.601 ring,” “heteroaryl group,” or “heteroaromatic,” any of which terms include rings that are optionally substituted.
  • heteroarylkyl refers to an alkyl group substituted by a heteroaryl, wherein the alkyl and heteroaryl portions independently are optionally substituted.
  • heterocycle As used herein, the terms “heterocycle,” “heterocyclyl,” “heterocyclic radical,” and “heterocyclic ring” are used interchangeably and refer to a stable 5– to 7–membered monocyclic or 7–10–membered bicyclic heterocyclic moiety that is either saturated or partially unsaturated, and having, in addition to carbon atoms, one or more, preferably one to four, heteroatoms, as defined above.
  • nitrogen includes a substituted nitrogen.
  • the nitrogen may be N (as in 3,4– dihydro–2H–pyrrolyl), NH (as in pyrrolidinyl), or + NR (as in N–substituted pyrrolidinyl).
  • a heterocyclic ring can be attached to its pendant group at any heteroatom or carbon atom that results in a stable structure and any of the ring atoms can be optionally substituted.
  • saturated or partially unsaturated heterocyclic radicals include, without limitation, tetrahydrofuranyl, tetrahydrothiophenyl pyrrolidinyl, piperidinyl, pyrrolinyl, tetrahydroquinolinyl, tetrahydroisoquinolinyl, decahydroquinolinyl, oxazolidinyl, piperazinyl, dioxanyl, dioxolanyl, diazepinyl, oxazepinyl, thiazepinyl, morpholinyl, and quinuclidinyl.
  • heterocycle used interchangeably herein, and also include groups in which a heterocyclyl ring is fused to one or more aryl, heteroaryl, or cycloaliphatic rings, such as indolinyl, 3H–indolyl, chromanyl, phenanthridinyl, or tetrahydroquinolinyl.
  • a heterocyclyl group may be mono– or bicyclic.
  • heterocyclylalkyl refers to an alkyl group substituted by a heterocyclyl, wherein the alkyl and heterocyclyl portions independently are optionally substituted.
  • partially unsaturated refers to a ring moiety that includes at least one double or triple bond.
  • partially unsaturated is intended to encompass rings having multiple sites of unsaturation, but is not intended to include aryl or heteroaryl moieties, as herein defined.
  • compounds of the invention may contain “optionally substituted” moieties.
  • substituted means that one or more hydrogens of the designated moiety are replaced with a suitable substituent.
  • an “optionally substituted” group may have a suitable substituent at each substitutable position of the group, and when more than one position in any given structure may be substituted with more than one substituent selected from a specified group, the substituent may be either the same or different at every position.
  • Combinations of substituents envisioned by this invention are preferably those that result in the formation of stable or WSGR Docket No.: 56017-729.601 chemically feasible compounds.
  • Suitable monovalent substituents on R ⁇ are independently halogen, —(CH 2 ) 0– 2R ⁇ , –(haloR ⁇ ), –(CH2)0–2OH, –(CH2)0–2OR ⁇ , –(CH2)0–2CH(OR ⁇ )2; -O(haloR ⁇ ), –CN, –N3, – (CH2)0–2C(O)R ⁇ , –(CH2)0–2C(O)OH, –(CH2)0–2C(O)OR ⁇ , –(CH2)0–2SR ⁇ , –(CH2)0–2SH, –(CH2)0– 2NH2, –(CH2)0–2NHR ⁇ , –(CH2)0–2NR ⁇ 2, –NO2, –SiR ⁇ 3, –OSiR
  • Suitable divalent substituents that are bound to vicinal substitutable carbons of an “optionally substituted” group include: –O(CR * 2)2– 3O–, wherein each independent occurrence of R * is selected from hydrogen, C1–6 aliphatic which may be substituted as defined below, or an unsubstituted 5–6–membered saturated, partially unsaturated, or aryl ring having 0–4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • Suitable substituents on the aliphatic group of R * include halogen, –R ⁇ , -(haloR ⁇ ), -OH, –OR ⁇ , –O(haloR ⁇ ), –CN, –C(O)OH, –C(O)OR ⁇ , –NH2, –NHR ⁇ , –NR ⁇ 2, or –NO2, wherein each R ⁇ is unsubstituted or where preceded by “halo” is substituted only with one or more halogens, and is independently C1–4 aliphatic, –CH2Ph, –O(CH2)0–1Ph, or a 5–6–membered saturated, partially unsaturated, or aryl ring having 0–4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • Suitable substituents on a substitutable nitrogen of an “optionally substituted” group include – C(O) wherein each R ⁇ is independently hydrogen, C1–6 aliphatic which may be substituted as defined below, unsubstituted –OPh, or an unsubstituted 5–6–membered saturated, partially unsaturated, or aryl ring having 0–4 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or, notwithstanding the definition above, two independent occurrences of R ⁇ , taken together with their intervening atom(s) form an unsubstituted 3–12–membered saturated, partially unsaturated, or aryl mono– or bicyclic ring having 0–4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • Suitable substituents on the aliphatic group of R ⁇ are independently halogen, – R ⁇ , -(haloR ⁇ ), –OH, –OR ⁇ , –O(haloR ⁇ ), –CN, –C(O)OH, –C(O)OR ⁇ , –NH2, –NHR ⁇ , –NR ⁇ 2, or -NO2, wherein each R ⁇ is unsubstituted or where preceded by “halo” is substituted only with one or more halogens, and is independently C1–4 aliphatic, –CH2Ph, –O(CH2)0–1Ph, or a 5–6– membered saturated, partially unsaturated, or aryl ring having 0–4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • WSGR Docket No.: 56017-729.601 Compounds From Semaglutide [00152] Disclosed herein, in some embodiments, are compounds comprising certain ionic salt forms (i.e., pharmaceutically acceptable salts), esters and/or prodrugs of semaglutide, having improved qualities, including enhanced stability and improved solubility in an aqueous environment, relative to the free acid form of semaglutide that is utilized in marketed therapies Ozempic ⁇ , Wegovy ⁇ and Rybelsus ⁇ . Also disclosed are other derivatives of semaglutide.
  • ionic salt forms i.e., pharmaceutically acceptable salts
  • esters and/or prodrugs of semaglutide having improved qualities, including enhanced stability and improved solubility in an aqueous environment, relative to the free acid form of semaglutide that is utilized in marketed therapies Ozempic ⁇ , Wegovy ⁇ and Rybelsus ⁇ .
  • other derivatives of semaglutide are also disclosed
  • salt As used herein, the terms “salt,” “salt form,” “ionic salt form” and “pharmaceutically acceptable salt,” as used herein, refers to those salts which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of humans and lower animals without undue toxicity, irritation, allergic response, and the like, and are commensurate with a reasonable benefit/risk ratio.
  • Pharmaceutically acceptable salts are well known in the art. For example, S. M. Berge et al., describe pharmaceutically acceptable salts in detail in J. Pharmaceutical Sciences, 1977, 66, 1–19, incorporated herein by reference.
  • Pharmaceutically acceptable salts of the compounds as provided herein include those derived from suitable inorganic and organic acids and bases.
  • the compound, or pharmaceutically acceptable salt thereof is a prodrug.
  • prodrug refers to compounds that are transformed in vivo to yield a disclosed compound or a pharmaceutically acceptable form of the compound.
  • a prodrug is converted in vivo to an active compound, for example, by hydrolysis (e.g., hydrolysis in blood).
  • a prodrug has improved physical and/or delivery properties over the parent compound.
  • Prodrugs are typically designed to enhance pharmaceutically and/or pharmacokinetically based properties associated with the parent compound.
  • the prodrug compound often offers advantages of solubility, tissue compatibility or delayed release in a mammalian organism (see, e.g., Bundgard, H., Design of Prodrugs (1985), pp. 7-9, 21-24 (Elsevier, Amsterdam).
  • prodrugs as Novel Delivery Systems
  • A.C.S. Symposium Series Vol. 14
  • Bioreversible Carriers in Drug Design ed. Edward B. Roche, American Pharmaceutical Association and Pergamon Press, 1987.
  • Exemplary advantages of a prodrug can include, but are not limited to, its physical properties, such as enhanced water solubility for parenteral administration at physiological pH WSGR Docket No.: 56017-729.601 compared to the parent compound, or it enhances absorption from the digestive tract, or it can enhance drug stability for long-term storage.
  • prodrug is also meant to include any covalently bonded carriers, which release the active compound in vivo when such prodrug is administered to a subject.
  • Prodrugs of an active compound, as described herein can be prepared by modifying functional groups present in the active compound in such a way that the modifications are cleaved, either in routine manipulation or in vivo, to the parent active compound.
  • Prodrugs include compounds wherein a hydroxy, amino or mercapto group is bonded to any group that, when the prodrug of the active compound is administered to a subject, cleaves to form a free hydroxy, free amino or free mercapto group, respectively.
  • prodrugs include, but are not limited to, acetate, formate and benzoate derivatives of an alcohol or acetamide, formamide and benzamide derivatives of an amine functional group in the active compound and the like.
  • a compound comprising an ionic salt form of semaglutide having the structure of Formula I: wherein: semaglutide; and
  • C18 diacid refers to fatty acid side chain of semaglutide having the structure –CO(CH2)16CO2.
  • ⁇ -Glu linker refers to the bivalent linker moiety of semaglutide having the structure –CO(CH 2 ) 2 CH(CO 2 )NH-.
  • R 8 , R 9 , and R 10 are independently C1-C5 alkyl, and R 11 is C2-C5 alkyl that is unsubstituted or substituted with one or more hydroxyl. In some embodiments, is not choline.
  • an anion of semaglutide having the structure , is meant to encompass from one (1) to seven (7) carboxylate anions of semaglutide corresponding to at least one carboxylate anion and up to seven carboxylate anions, the total number of carboxylic acid moieties on the semaglutide peptide.
  • the anion of semaglutide has from one (1) to seven (7) anions of semaglutide, as represented by Formula Ia1: Formula Ia1.
  • the anion of semaglutide is one anion of semaglutide, as represented by Formula Ia1-1: Formula Ia1-1, [00163] In some embodiments, the anion of semaglutide, is two anions of semaglutide, as represented by Formula Ia1-2: Formula Ia1-2. WSGR Docket No.: 56017-729.601 [00164] In some embodiments, the anion of semaglutide, is three anions of semaglutide, as represented by Formula Ia1-3: Formula Ia1-3. [00165] In some embodiments, the anion of semaglutide, is four anions of semaglutide, as represented by Formula Ia1-4: Formula Ia1-4.
  • the anion of semaglutide is five anions of semaglutide, as represented by Formula Ia1-5: Formula Ia1-5.
  • the anion of semaglutide is six anions of semaglutide, as represented by Formula Ia1-6: Formula Ia1-6.
  • the anion of semaglutide is seven anions of semaglutide, as represented by Formula Ia1-7: Formula Ia1-7.
  • a “cationic component,” having the structure is meant to encompass from about one (1) to seven (7) cations corresponding to at least one cation and up to seven cations, provided as counterion(s) to the total potential number of carboxylate moieties on the semaglutide peptide.
  • the cationic component has from about one (1) to seven (7) cations.
  • the cationic component is one cation, corresponding to a molar ratio of semaglutide anion to cationic component of about 1:1.
  • the cationic component is two cations, corresponding to a molar ratio of semaglutide anion to cationic component of about 1:2. In some embodiments, the cationic component is three cations, corresponding to a molar ratio of semaglutide anion to cationic component of about 1:3. In some embodiments, the cationic component is four cations, corresponding to a molar ratio of semaglutide anion to cationic component of about 1:4. In some embodiments, the cationic component is five cations, corresponding to a molar ratio of semaglutide anion to cationic component of about 1:5.
  • the cationic component is six cations, corresponding to a molar ratio of semaglutide anion to cationic component of about 1:6. In some embodiments, the cationic component is seven cations, corresponding to a molar ratio of semaglutide anion to cationic component of about 1:7.
  • a compound comprising the structure of Formula Ia2: Formula Ia2, wherein: from one to seven anions of semaglutide; and cationic component.
  • the compound of Formula 1a2 is a compound having the structure of: Formula Ia2-1.
  • the compound of Formula 1a2 is a compound having the structure of: WSGR Docket No.: 56017-729.601 Formula Ia2-2. [00173] In some embodiments, the compound of Formula 1a2 is a compound having the structure of: Formula Ia2-3. [00174] In some embodiments, the compound of Formula 1a2 is a compound having the structure of: Formula Ia2-4. [00175] In some embodiments, the compound of Formula 1a2 is a compound having the structure of: Formula Ia2-5. [00176] In some embodiments, the compound of Formula 1a2 is a compound having the structure of: Formula Ia2-6.
  • the compound of Formula 1a2 is a compound having the structure of: Formula Ia2-7.
  • the cationic component of R 2 derives from appropriate bases and is selected from the group consisting of alkali metal, alkaline earth metal, a metal ion such as aluminum, sodium, lithium, potassium, magnesium, calcium, and zinc, ammonium (NH4 + ), a WSGR Docket No.: 56017-729.601 protonated or positively (+) charged ion from an aliphatic primary amine, secondary amine or tertiary amine such as 2-aminoethanol, tromethamine, dimethylamine, diethylamine, N-ethyl- glucamine, hydrabamine, trimethylamine, triethylamine, dicyclohexylamine, ethanolamine, diethanolamine, triethanolamine, dimethylethanolamine, (2,2′,2′′-nitrilotris(ethanol)), 2- die
  • the cationic component of R 2 is not choline.
  • the cationic component is betaine.
  • the cationic component comprises the structure of: .
  • the cationic component has the structure of: .
  • betaine refers to a compound having a central methylene carbon (-CH2-) attached to an anionic carboxylate group - (CO2-) on one side and a positively charged cationic quaternary ammonium group -(N(CH3)3+) on the other, where the compound acts as a zwitterion having both positive and negative charges within the same molecule, as shown below.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7, or any ratio between any two of these values.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:7.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7, or any ratio between any two of these values.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4.
  • the cationic component is selected from the group of cationic components listed in Table 3. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7, or any ratio between any two of these values. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a weight % (wt. %) ratio relative to the anion of semaglutide as listed in Table 3.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:7.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:6 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:6.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:5. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:4. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:3.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:2. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:6.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:5. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:4. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:3.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:6. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of WSGR Docket No.: 56017-729.601 anion of semaglutide to cationic component that is from about 1:3 to about 1:5.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:4. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:6.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:5. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:7. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:6.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:1. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:2. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:3. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4.
  • the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:5. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:6. In some embodiments, the cationic component and anion of semaglutide are provided in a molar ratio of anion of semaglutide to cationic component that is about 1:7.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:7.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:7.
  • the cationic component is WSGR Docket No.: 56017-729.601 selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:6 to about 1:7.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:6.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:5. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:4. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:3.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:2. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:6. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:5.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:4. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:3.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar WSGR Docket No.: 56017-729.601 ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:6.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:5. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:4.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:6.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:5. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:7.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:6. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:1. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:2.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:3. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4.
  • the cationic component is selected from the group of cationic components described WSGR Docket No.: 56017-729.601 herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:5. In some embodiments, the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:6.
  • the cationic component is selected from the group of cationic components described herein or listed in the preceding paragraphs, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:6 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:6. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:5. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:4.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:3. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:1 to about 1:2. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio WSGR Docket No.: 56017-729.601 of anion of semaglutide to cationic component that is from about 1:2 to about 1:6. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:5. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:4.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:2 to about 1:3. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:7. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:6.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:5. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:3 to about 1:4. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:6. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:4 to about 1:5. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:7.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is from about 1:5 to about 1:6. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:1. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:2.
  • the cationic component is selected from the group of cationic WSGR Docket No.: 56017-729.601 components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:3.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:4.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:5.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:6. In some embodiments, the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is about 1:7. [00184] In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:1 to about 1:7.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:2 to about 1:7. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:3 to about 1:7. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:4 to about 1:7.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:5 to about 1:7. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:6 to about 1:7. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:1 to about 1:6. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:1 to about 1:5.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:1 to about 1:4. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:1 to about 1:3. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:1 to about 1:2. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:2 to about 1:7.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:2 to about 1:6. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:2 to about 1:5. In some embodiments, the anion of semaglutide and betaine WSGR Docket No.: 56017-729.601 are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:2 to about 1:4.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:2 to about 1:3. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:3 to about 1:7. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:3 to about 1:6. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:3 to about 1:5.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:3 to about 1:4. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:4 to about 1:7. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:4 to about 1:6.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:4 to about 1:5. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:5 to about 1:7. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is from about 1:5 to about 1:6. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is about 1:1.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is about 1:2. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is about 1:3. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is about 1:4. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is about 1:5.
  • the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to betaine that is about 1:6. In some embodiments, the anion of semaglutide and betaine are provided in a molar ratio of anion of semaglutide to quaternary ammonium that is about 1:7.
  • representative alkali or alkaline earth metal salts include, but are not limited to, aluminum, sodium, lithium, potassium, calcium, magnesium, zinc and the like.
  • N(C1–4alkyl) 4+ includes tetramethyl ammonium, tetraethyl ammonium, acetylcholine, tetrapropyl ammonium and tetrabutyl ammonium.
  • the quaternary ammonium has the structure wherein: R 8 , R 9 , R 10 , and R 11 are each independently a substituted or unsubstituted group selected from C 1- 6 aliphatic, phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • the quaternary ammonium has the structure wherein: three of R 8 , R 9 , R 10 , and R 11 are each independently a substituted or unsubstituted C1-6 aliphatic, and one of R 8 , R 9 , R 10 , and R 11 is substituted or unsubstituted phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • the quaternary ammonium has the structure wherein: two of R 8 , R 9 , R 10 , and R 11 are each independently a substituted or unsubstituted C1-6 aliphatic, and two of R 8 , R 9 , R 10 , and R 11 is each independently substituted or unsubstituted phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • the quaternary ammonium has the structure of wherein: one of R 8 , R 9 , R 10 , and R 11 is a substituted or unsubstituted C1-6 aliphatic, and three of R 8 , R 9 , R 10 , and R 11 is each independently substituted or unsubstituted phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or 5-6 membered monocyclic heteroaryl WSGR Docket No.: 56017-729.601 ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, or sulfur.
  • the quaternary ammonium has the structure of wherein: R 8 , R 9 , R 10 , and R 11 are each independently a substituted or unsubstituted C1-6 aliphatic. [00192] In some embodiments, the quaternary ammonium has the structure wherein: (i) R 8 , R 9 , R 10 , and R 1 are independently substituted or unsubstituted C1-C6 alkyl; (ii) R 8 , R 9 , R 10 , and R 11 are independently C1-C4 alkyl (N(C1–4alkyl)4 + ); (iii) R 8 , R 9 , and R 10 are C2 alkyl; and R 11 is C1 alkyl; (iv) R 8 , R 9 , and R 10 are C4 alkyl; and R 11 is C1 alkyl; (v) all of R 8 , R 9 , R 10 , and R 11 are C1 alkyl;
  • the quaternary ammonium has the structure of , wherein R 8 , R 9 , R 10 , and R 11 are each independently substituted or unsubstituted C1-C20 alkyl or an aryl.
  • the cationic component is a quaternary ammonium, with the proviso that the cationic component does not have the structure , wherein R 8 , R 9 , and R 10 are independently C1-C5 alkyl, and R 11 is C2-C5 alkyl that is unsubstituted or substituted with 1 or more hydroxyl.
  • the cationic component is a quaternary ammonium comprising substituted or unsubstituted C6-C20 alkyl or an aryl.
  • the cationic component is a quaternary ammonium, wherein the anion of semaglutide and quaternary ammonium are provided in a molar ratio of anion of semaglutide to quaternary ammonium that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7, or any ratio between any two of these values.
  • the WSGR Docket No.: 56017-729.601 cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7, or any ratio between any two of these values.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:1 to about 1:7. In some embodiments, the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:2 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of WSGR Docket No.: 56017-729.601 semaglutide to the quaternary ammonium having the structure of that is from about 1:3 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:4 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:5 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:6 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the WSGR Docket No.: 56017-729.601 structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure that is from about 1:3 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure that is from about 1:1 to about 1:6. In some embodiments, the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:1 to about 1:5.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:1 to about 1:4.
  • the cationic component is a quaternary ammonium having the structure of WSGR Docket No.: 56017-729.601 , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:1 to about 1:3.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:1 to about 1:2. In some embodiments, the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:2 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary WSGR Docket No.: 56017-729.601 ammonium having the structure of that is from about 1:2 to about 1:6.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:2 to about 1:5.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:2 to about 1:4.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:2 to about 1:3.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the WSGR Docket No.: 56017-729.601 structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure that is from about 1:3 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure that is from about 1:3 to about 1:6.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:3 to about 1:5.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:3 to about 1:4.
  • the cationic component is a quaternary ammonium having the structure of WSGR Docket No.: 56017-729.601 , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:4 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:4 to about 1:6.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:4 to about 1:5.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary WSGR Docket No.: 56017-729.601 ammonium having the structure of that is from about 1:5 to about 1:7.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is from about 1:5 to about 1:6.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is about 1:1.
  • the cationic component is a quaternary ammonium having the structure wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is about 1:2.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the WSGR Docket No.: 56017-729.601 quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is about 1:3.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is about 1:4. In some embodiments, the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is about 1:5.
  • the cationic component is a quaternary ammonium having the structure of , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure that is about 1:6.
  • the cationic component is a quaternary ammonium having the structure of WSGR Docket No.: 56017-729.601 , wherein the anion of semaglutide and the quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to the quaternary ammonium having the structure of that is about 1:7.
  • the quaternary ammonium has the structure of , wherein R 15 , R 16 , R 17 are each independently a substituted or unsubstituted group selected from C1-6 aliphatic, phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, or sulfur; R 18 , R 19 , R 20 , and R 21 are each independently hydrogen, halogen, substituted or unsubstituted C 1- 6 aliphatic; and R 22 is hydrogen, or substituted or unsubstituted group selected from -C(O)-C1-6 aliphatic, C1-6 aliphatic, phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently
  • R 22 is selected from the group consisting of -C(O)CH3, -C(O)CF3, -C(O)CH2F, -C(O)CHF2, -CH3, -CF3, -CH2F, -CHF2, -CH2CH3, and -CH2CH2CH3, and CH(CH3)2
  • the quaternary ammonium has the structure of , wherein R 15 , R 16 , R 17 are each independently a substituted or unsubstituted group selected from C 1-6 aliphatic, phenyl, cycloalkyl, 4-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, or sulfur, or 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from WSGR Docket No.: 56017-729.601 nitrogen, oxygen, or sulfur; R 18 , R 19
  • R 23 is selected from the group consisting of -CH3, -CF3, -CH2F, and -CHF2.
  • the cationic component is a quaternary ammonium having the structure wherein the anion of semaglutide and quaternary ammonium having the structure of or are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7 or any ratio between any two of these values.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure WSGR Docket No.: 56017-729.601 ammonium having the structure that is from about 1:2 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:3 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:4 to about 1:7.
  • the anion of WSGR Docket No.: 56017-729.601 semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:5 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:6 to about 1:7. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:1 to about 1:6.
  • the anion of semaglutide and quaternary ammonium having the structure WSGR Docket No.: 56017-729.601 are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:1 to about 1:5. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:1 to about 1:4.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure WSGR Docket No.: 56017-729.601 ammonium having the structure that is from about 1:1 to about 1:2. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:2 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of ammonium having the structure that is from about 1:2 to about 1:5.
  • the anion of semaglutide and quaternary ammonium WSGR Docket No.: 56017-729.601 having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:2 to about 1:4.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure ammonium having the structure that is from about 1:3 to about 1:7. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of WSGR Docket No.: 56017-729.601 that is from about 1:3 to about 1:6.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure ammonium having the structure that is from about 1:3 to about 1:4. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:4 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure of WSGR Docket No.: 56017-729.601 are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure ammonium having the structure that is from about 1:4 to about 1:5. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of that is from about 1:5 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of WSGR Docket No.: 56017-729.601 semaglutide to quaternary ammonium having the structure ammonium having the structure that is about 1:1. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:2.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:3.
  • the WSGR Docket No.: 56017-729.601 anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:4.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:5.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:6. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary WSGR Docket No.: 56017-729.601 ammonium having the structure that is about 1:7. [00202] In some embodiments, the quaternary ammonium has the structure selected from the , [00203] In some embodiments, the quaternary ammonium has the structure of .
  • the cationic component is a quaternary ammonium having the structure , wherein the anion of semaglutide and quaternary ammonium having the structure , are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7 or any ratio between any two of these values.
  • the anion of semaglutide and quaternary ammonium having the WSGR Docket No.: 56017-729.601 structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure of or that is from about 1:1 to about 1:7. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure of , are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:2 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:3 to about 1:7.
  • the anion WSGR Docket No.: 56017-729.601 of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:4 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:5 to about 1:7. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:6 to about 1:7.
  • the anion WSGR Docket No.: 56017-729.601 of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:1 to about 1:6. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure of , are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:1 to about 1:5.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:1 to about 1:4.
  • the anion WSGR Docket No.: 56017-729.601 of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:1 to about 1:3.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:1 to about 1:2. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:2 to about 1:7.
  • the anion WSGR Docket No.: 56017-729.601 of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:2 to about 1:6. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure of , are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:2 to about 1:5.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:2 to about 1:4.
  • the anion WSGR Docket No.: 56017-729.601 of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:2 to about 1:3.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:3 to about 1:7. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:3 to about 1:6.
  • the anion WSGR Docket No.: 56017-729.601 of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:3 to about 1:5. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure of , are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:3 to about 1:4.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:4 to about 1:7.
  • the anion WSGR Docket No.: 56017-729.601 of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:4 to about 1:6.
  • the anion of semaglutide and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:4 to about 1:5. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is from about 1:5 to about 1:7.
  • the anion of semaglutide and quaternary ammonium having the structure of provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:2.
  • the anion of semaglutide WSGR Docket No.: 56017-729.601 and quaternary ammonium having the structure of are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:3.
  • the anion of semaglutide and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:4. In some embodiments, the anion of semaglutide and quaternary ammonium having the structure , provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:5.
  • the anion of semaglutide WSGR Docket No.: 56017-729.601 and quaternary ammonium having the structure are provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure that is about 1:6.
  • the anion of semaglutide and quaternary ammonium having the structure of provided in a molar ratio of anion of semaglutide to quaternary ammonium having the structure [00206]
  • the cationic component is choline. In some embodiments, the cationic component is acetylcholine.
  • the cationic component is choline wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7 or any ratio between any two of these values.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:1 to about 1:7.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:2 to about 1:7. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:3 to about 1:7.
  • the cationic component is choline, wherein the anion of semaglutide and choline WSGR Docket No.: 56017-729.601 are provided in a molar ratio of anion of semaglutide to choline that is from about 1:4 to about 1:7. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:5 to about 1:7.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:6 to about 1:7. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:1 to about 1:6. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:1 to about 1:5.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:1 to about 1:4. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:1 to about 1:3. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:1 to about 1:2.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:2 to about 1:7. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:2 to about 1:6. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:2 to about 1:5.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:2 to about 1:4. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:2 to about 1:3. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:3 to about 1:7.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:3 to about 1:6. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:3 to about 1:5.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is WSGR Docket No.: 56017-729.601 from about 1:3 to about 1:4.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:4 to about 1:7.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:4 to about 1:6. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:4 to about 1:5. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:5 to about 1:7.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is from about 1:5 to about 1:6. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is about 1:1. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is about 1:2.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is about 1:3. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is about 1:4. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is about 1:5.
  • the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is about 1:6. In some embodiments, the cationic component is choline, wherein the anion of semaglutide and choline are provided in a molar ratio of anion of semaglutide to choline that is about 1:7.
  • the cationic component is acetylcholine wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7 or any ratio between any two of these values.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:1 to about 1:7.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:2 to about 1:7.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to WSGR Docket No.: 56017-729.601 acetylcholine that is from about 1:3 to about 1:7.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:4 to about 1:7. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:5 to about 1:7.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:6 to about 1:7. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:1 to about 1:6.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:1 to about 1:5. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:1 to about 1:4.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:1 to about 1:3. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:1 to about 1:2.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:2 to about 1:7. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:2 to about 1:6.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:2 to about 1:5. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:2 to about 1:4.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:2 to about 1:3. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:3 to about 1:7.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to WSGR Docket No.: 56017-729.601 acetylcholine that is from about 1:3 to about 1:6.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:3 to about 1:5.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:3 to about 1:4. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:4 to about 1:7.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:4 to about 1:6. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:4 to about 1:5.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:5 to about 1:7. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is from about 1:5 to about 1:6.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is about 1:1. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is about 1:2.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is about 1:3. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is about 1:4.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is about 1:5. In some embodiments, the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is about 1:6.
  • the cationic component is acetylcholine, wherein the anion of semaglutide and acetylcholine are provided in a molar ratio of anion of semaglutide to acetylcholine that is about 1:7.
  • the cationic component excludes choline.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline selected from the WSGR Docket No.: 56017-729.601 group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 and 1:7 or any ratio between any two of these values.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:1 to about 1:7.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:2 to about 1:7. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:3 to about 1:7.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:4 to about 1:7. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:5 to about 1:7.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:6 to about 1:7. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:1 to about 1:6.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:1 to about 1:5. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:1 to about 1:4.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:1 to about 1:3. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:1 to about 1:2.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:2 to about 1:7. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:2 to about 1:6.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of WSGR Docket No.: 56017-729.601 anion of cagrilintide to the cationic component that excludes choline that is from about 1:2 to about 1:5. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:2 to about 1:4.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:2 to about 1:3. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:3 to about 1:7.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:3 to about 1:6. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:3 to about 1:5.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:3 to about 1:4. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:4 to about 1:7.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:4 to about 1:6. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:4 to about 1:5.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:5 to about 1:7. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is from about 1:5 to about 1:6.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is about 1:1. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is about 1:2.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component WSGR Docket No.: 56017-729.601 that excludes choline that is about 1:3. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is about 1:4.
  • the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is about 1:5. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is about 1:6. In some embodiments, the anion of semaglutide and the cationic component that excludes choline are provided in a molar ratio of anion of cagrilintide to the cationic component that excludes choline that is about 1:7.
  • a hydrate of the compound of Formula I means a solid or a semi-solid form of a chemical compound containing water in a molecular complex. The water is generally in a stoichiometric amount with respect to the chemical compound.
  • Exemplary hydrates include (compound of Formula I • ZH2O), wherein Z is from 1 to 50 equivalents of H2O.
  • Z is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50. In some embodiments, Z is between any two of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 and 50.
  • the cationic component is a quaternary ammonium having the structure of , wherein R 8 , R 9 , and R 10 are independently C1-C5 alkyl, and R 11 is C2- C5 alkyl that is unsubstituted or substituted with 1 or more hydroxyl.
  • R 8 , R 9 , and R 10 are independently C1-C5 alkyl, and R 11 is C2- C5 alkyl that is unsubstituted or substituted with 1 or more hydroxyl.
  • a compound comprising an ionic salt form of semaglutide having the structure of Formula IIa, Formula IIb, Formula IIc, or any combination thereof: Formula IIa, WSGR Docket No.: 56017-729.601 Formula IIb, Formula IIc, wherein , , , or any combination thereof is one or more cations of semaglutide; and anionic component.
  • a compound consisting, or consisting essentially, of the structure of Formula IIa, Formula IIb, Formula IIc, or any combination thereof is provided herein.
  • “one or more cations of semaglutide,” having the structure , , , or any combination thereof, is meant to encompass from one (1) to four (4) cations of semaglutide corresponding to at least one protonated amino moiety and up to five protonated amino moieties of semaglutide, the total number of basic amino moieties on the semaglutide peptide.
  • the one or more cations of semaglutide, having the structure any combination thereof has from one (1) to four (4) cations of semaglutide.
  • the one or more cations of semaglutide is one cation of semaglutide. In some embodiments, the one or more cations of semaglutide is two cations of semaglutide. In some embodiments, the one or more cations of semaglutide is three cations of semaglutide. In some embodiments, the one or more cations of semaglutide is four cations of semaglutide.
  • the “anionic component,” having the structure is meant to encompass from about one (1) to four (4) anions corresponding to at least one anion and up to five anions, provided as counterion(s) to the total potential number of protonated basic amino moieties on the semaglutide peptide.
  • the anionic component of semaglutide has from about one (1) to four (4) anions of semaglutide.
  • the anionic component is one anion, corresponding to a molar ratio of one or more cations of semaglutide to anionic component of about 1:1.
  • the anionic component is two anions, corresponding to a molar ratio of one or more cations of semaglutide to anionic component of about 1:2. In some embodiments, the anionic component is three anions, corresponding to a molar ratio of one or more cations of semaglutide to anionic component of about 1:3. In some embodiments, the anionic component is four anions, corresponding to a molar ratio of one or more cations of semaglutide to anionic component of about 1:4. [00215] In some embodiments, the one or more cations of semaglutide derive from the structure of the compound in Table 2.
  • the anionic component of R 7 include, but are not limited to, inorganic acids such as hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid and perchloric acid or with organic acids such as acetic acid, oxalic acid, maleic acid, tartaric acid, citric acid, succinic acid, or malonic acid or by using other methods used in the art such as ion exchange.
  • inorganic acids such as hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid and perchloric acid
  • organic acids such as acetic acid, oxalic acid, maleic acid, tartaric acid, citric acid, succinic acid, or malonic acid or by using other methods used in the art such as ion exchange.
  • the anionic component of R 7 is selected from the group consisting of besylate, mesylate, tosylate, sulfonate, sulfate, methylsulfate, camsylate, isethionate, edisylate, 1-hydroxy-2-naphthoate, 2,2-dichloroacetate, 2-hydroxyethanesulfonate, 2-oxoglutarate, 4- acetamidobenzoate, 4-aminosalicylate, acetate, adipate, ascorbate, aspartate, benzenesulfonate, benzoate, bromide, chloride, camphorate, camphor-10-sulfonate, caprate (decanoate), caproate (hexanoate), caprylate (octanoate), carbonate, cinnamate, citrate, cyclamate, dodecylsulfate, dodecylsulfurate,
  • the anionic component ( ) is betaine. In some embodiments, the anionic component ( ) comprises the structure of: In some embodiments, the anionic component ( ) has the structure of: [00218] In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:1, 1:2, 1:3, or 1:4, or any ratio between any two of these values. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:4.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of WSGR Docket No.: 56017-729.601 semaglutide to anionic component that is about 1:1, 1:2, 1:3, or 1:4, or any ratio between any two of these values.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from about 1:1 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from about 1:2 to about 1:4. In some embodiments, the anionic component is selected from the group of cationic components listed in Table 4.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is about 1:1, 1:2, 1:3, or 1:4, or any ratio between any two of these values. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from 1:1 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is from 1:2 to about 1:4.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a weight % (wt. %) ratio relative to the one or more cations of semaglutide as listed in Table 4.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:4.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:3 to about 1:4. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:3. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:2.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:3. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of WSGR Docket No.: 56017-729.601 semaglutide to anionic component of from about 1:3 to about 1:4.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:1. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:2. In some embodiments, the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:3.
  • the one or more cations of semaglutide and anionic component are provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:4.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:4.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:3 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:3. In some embodiments, the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:2.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:3. In some embodiments, the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:3 to about 1:4.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:1. In some embodiments, the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:2. In some embodiments, the anionic component is selected from the group of anionic components described WSGR Docket No.: 56017-729.601 herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:3.
  • the anionic component is selected from the group of anionic components described herein, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:4. [00221] In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:3 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:3. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:1 to about 1:2.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:4. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:2 to about 1:3. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of from about 1:3 to about 1:4.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:1. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:2. In some embodiments, the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:3.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component of about 1:4.
  • the one or more cations of semaglutide and betaine are provided WSGR Docket No.: 56017-729.601 in a molar ratio of one or more cations of semaglutide to betaine of from about 1:1 to about 1:4.
  • the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of from about 1:2 to about 1:4.
  • the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of from about 1:3 to about 1:4. In some embodiments, the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of from about 1:1 to about 1:3. In some embodiments, the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of from about 1:1 to about 1:2.
  • the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of from about 1:2 to about 1:4. In some embodiments, the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of from about 1:2 to about 1:3. In some embodiments, the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of from about 1:3 to about 1:4.
  • the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of about 1:1. In some embodiments, the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of about 1:2. In some embodiments, the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of about 1:3.
  • the one or more cations of semaglutide and betaine are provided in a molar ratio of one or more cations of semaglutide to betaine of about 1:4.
  • provided is a hydrate of the compound of Formula IIa, Formula IIb, Formula IIc, or any combination thereof.
  • Exemplary hydrates include (compound of Formula IIa, Formula IIb, Formula IIc, or any combination thereof • ZH2O), wherein Z is from 1 to 50.
  • Z is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50. In some embodiments, Z is between any two of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 and 50.
  • a compound comprising the structure of Formula IIIa: WSGR Docket No.: 56017-729.601 Formula IIIa or a pharmaceutically acceptable salt thereof; wherein: is a covalent derivative of one or more carboxyl groups of semaglutide, or a pharmaceutically acceptable salt thereof, wherein the covalent derivative of one or more carboxyl groups are of the C18 diacid, ⁇ -Glu linker, Glu residues, and/or Asp residues of semaglutide; and each R 100 is independently selected from an optionally substituted group consisting of C1-6 aliphatic, (C1-22)alkyl, (C1-22)alkenyl, -C(O)R, -C(O)OR, -C(O)N(R)2, phenyl, 3-8 membered saturated or partially unsaturated monocyclic carbocyclic ring, an 8-10 membered bicyclic aromatic carbocyclic ring, a 4-8 membere
  • the compound of Formula IIIa does not have the structure of Formula II, wherein R 8 , R 9 , and R 10 are independently C1-C5 alkyl.
  • R 100 is substituted C1-6 aliphatic, unsubstituted C1-6 aliphatic, substituted (C1-22)alkyl, unsubstituted (C1-22)alkyl, substituted (C1-22)alkenyl, unsubstituted (C1- 22)alkenyl, substituted phenyl, unsubstituted phenyl, substituted -C(O)R, unsubstituted -C(O)R, substituted -C(O)OR, unsubstituted -C(O)OR, substituted -C(O)N(R)2, or unsubstituted - WSGR Docket No.: 56017-729.601 C(O)N(R)2.
  • R 100 is methyl, ethyl, n-propyl, iso-propyl, n-butyl, iso-butyl, tert- butyl, or pentyl. In some embodiments, R 100 is fluoromethyl, difluoromethyl, or trifluoromethyl. In some embodiments, R 100 is CHCH3OC(O)OCH2CH3.
  • R 100 is -CH3, -CH2CH3, -CH(CH3)2, CH2CH2CH2CH3, C(CH3)3, -CH2CH2N(CH3)3 + [00229] In some embodiments, R 100 is (C2-C12)alkanoyloxymethyl, 1-(alkanoyloxy)ethyl having from 4 to 9 carbon atoms, 1-methyl-1-(alkanoyloxy)-ethyl having from 5 to 10 carbon atoms, alkoxycarbonyloxymethyl having from 3 to 6 carbon atoms, 1-(alkoxycarbonyloxy)ethyl having from 4 to 7 carbon atoms, 1-methyl-1-(alkoxycarbonyloxy)ethyl having from 5 to 8 carbon atoms, N-(alkoxycarbonyl)aminomethyl having from 3 to 9 carbon atoms, 1-(N- (alkoxycarbonyl)amino)ethyl having from 4 to 10 carbon atoms,
  • the compound of Formula IIIa is formed from the carboxyl of the –CO(CH2)16CO2 diacid moiety of semaglutide. [00231] In some embodiments, the compound of Formula IIIa is formed from the carboxyl of the ( ⁇ Glu) linker of semaglutide. [00232] In some embodiments, the compound of Formula IIIa is formed from the side chain carboxyl of one or more aspartic acid or glutamic acid residues of semaglutide. [00233] In some embodiments, provided herein is a compound comprising the structure of Formula IIIa1: Formula IIIa1. or a pharmaceutically acceptable salt thereof.
  • a compound comprising the structure of Formula IIIa1-1 WSGR Docket No.: 56017-729.601 Formula IIIa1-1 or a pharmaceutically acceptable salt thereof.
  • a compound comprising the structure of Formula IIIa1-1: Formula IIIa1-1 or a pharmaceutically acceptable salt thereof; wherein R 100 is -CH3, -CH2CH3, -CH(CH3)2, CH2CH2CH2CH3, C(CH3)3, or -CH2CH2N(CH3)3 + , and the compound of Formula IIIa1-1 is formed from the terminal carboxyl moiety of the –CO(CH2)16CO2 diacid moiety of semaglutide.
  • a compound comprising the structure of Formula IIIa1-2: Formula IIIa1-2 or a pharmaceutically acceptable salt thereof.
  • provided herein is a compound comprising the structure of Formula IIIa1-3: WSGR Docket No.: 56017-729.601 Formula IIIa1-3 or a pharmaceutically acceptable salt thereof.
  • a compound comprising the structure of Formula IIIa1-4 Formula IIIa1-4 or a pharmaceutically acceptable salt thereof.
  • a compound comprising the structure of Formula IIIa1-6 Formula IIIa1-6 or a pharmaceutically acceptable salt thereof.
  • a compound comprising the structure of Formula IIIa1-7: Formula IIIa1-7 or a pharmaceutically acceptable salt thereof.
  • a hydrate of the compound of Formula IIIa include (compound of Formula IIIa • ZH2O), wherein Z is from 1 to 50.
  • Z is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50.
  • Z is between any two of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 and 50.
  • a compound comprising the structure of Formula IIIb: ; Formula IIIb or a pharmaceutically acceptable salt thereof wherein: is a covalent derivative of one or more hydroxyl groups of semaglutide, or a pharmaceutically acceptable salt thereof; wherein one or more hydroxyl groups of the Ser residues, Thr residues, and/or Tyr residues of semaglutide are in the form of ; and each R 101 is independently selected from an optionally substituted group consisting of -CH2R, - C(O)R (such as -C(O)CH3 or -C(O)H), -C(O)OR (such as -C(O)OH2), -C(O)N(R)2 (such as - C(O)NH2 or -C(O)N(CH3)2), -OP(O)OROR (such as -OP(O)OHOH); and each occurrence of R is independently hydrogen or an optionally substituted group selected from -CH2R, - C(O)R (such as
  • R 101 is -CH2OCH2CH2OH, unsubstituted C(O)C1-6alkyl such as COCH3, COCH2CH3, or COCH(CH3)2). In some embodiments, R 101 is substituted C(O)C1-6alkyl such as COCF3, COCHCF2, or -COCH2CF. In some embodiments, R 101 is substituted C(O)phenyl or unsubstituted C(O)phenyl.
  • R 101 is -(C1-C6)alkanoyloxymethyl, -1-((C1- C6)alkanoyloxy)ethyl, -1-methyl-1-((C1-C6)alkanoyloxy)ethyl, -(C1- C6)alkoxycarbonyloxymethyl, -N-(C1-C6)alkoxycarbonylaminomethyl, -succinoyl, -(C1- WSGR Docket No.: 56017-729.601 C6)alkanoyl, - ⁇ -amino(C1-C4)alkanoyl, -arylacyl and - ⁇ -aminoacyl, or - ⁇ -aminoacyl- ⁇ - aminoacyl, where each ⁇ -aminoacyl group is independently selected from the naturally occurring L-amino acids, P(O)(OH)2, -P(O)(O(C1-C6)alkyl)2 or glyco
  • R 101 is CHCH3OC(O)OCH2CH3.
  • the compound of Formula IIIb is formed from the side chain hydroxyl moiety of one or more serine, threonine or tyrosine residues of semaglutide.
  • a compound comprising the structure of Formula IIIb1: Formula IIIb1 or a pharmaceutically acceptable salt thereof is provided herein.
  • provided herein is a compound comprising the structure of Formula IIIb1-2: Formula IIIb1-2 or a pharmaceutically acceptable salt thereof.
  • WSGR Docket No.: 56017-729.601 In some embodiments, provided herein is a compound comprising the structure of Formula IIIb1-4: Formula IIIb1-4 or a pharmaceutically acceptable salt thereof.
  • provided herein is a compound comprising the structure of Formula IIIb1-5: Formula IIIb1-5 or a pharmaceutically acceptable salt thereof.
  • a compound comprising the structure of Formula IIIb1-6: Formula IIIb1-6 or a pharmaceutically acceptable salt thereof.
  • a hydrate of the compound of the structure of Formula IIIb include (compound of Formula IIIb • ZH2O), wherein Z is from 1 to 50.
  • Z is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50.
  • Z is between any two of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 and 50.
  • a compound comprising the structure of Formula IIIc and/or Formula IIId: WSGR Docket No.: 56017-729.601 Formula IIIc Formula IIId or a pharmaceutically acceptable salt or each thereof; wherein: is a covalent derivative of one or more amino groups of semaglutide, or a pharmaceutically acceptable salt thereof; wherein the one or more amino groups of the Arg residues and/or terminal amino group of semaglutide are in the form of ; is a covalent derivative of the imidazole group of semaglutide, or a pharmaceutically acceptable salt thereof; wherein the imidazole group of the His residue of semaglutide is in the form of , and each R 102 and R 103 is independently selected from an optionally substituted group consisting of - CH2R, -C(O)R (such as -C(O)CH3 -C(O) CH2CH3 or -C(O)H), -C(O)OR
  • each R 102 and R 103 is independently -CH2OCH2CH2OH, unsubstituted C(O)C1-6alkyl such as COCH3, COCH2CH3, or COCH(CH3)2).
  • R 102 is substituted C(O)C1-6alkyl such as COCF3, COCHCF2, or -COCH2CF.
  • R 102 is substituted C(O)phenyl or unsubstituted C(O)phenyl.
  • R 102 is CHCH3OC(O)OCH2CH3.
  • each R 102 and R 103 is independently C(O)R, C(O)OR, C(O)NR’R”, where R’ and R” are each independently (C1-C10)alkyl, (C3-C7)cycloalkyl, benzyl, or C(O)R’ is a natural ⁇ -aminoacyl or natural ⁇ -aminoacyl-natural ⁇ -aminoacyl, - C(OH)C(O)OY 1 wherein Y 1 is H, (C1-C6)alkyl or benzyl, -C(OY 2 )Y 3 wherein Y 2 is (C1-C4) alkyl and Y 3 is (C1-C6)alkyl, carboxy(C1-C6)alkyl, amino(C1-C4)alkyl or mono-N-or di-N,N-(C1- C6)alkylaminoalkyl, -C(Y 4 )Y 5 wherein
  • provided herein is a compound comprising the structure of Formula IIIc1 Formula IIIc1 or a pharmaceutically acceptable salt thereof.
  • WSGR Docket No.: 56017-729.601 In some embodiments, provided herein is a compound comprising the structure of Formula IIIc1-2: Formula IIIc1-2 or a pharmaceutically acceptable salt thereof.
  • provided herein is a compound comprising the structure of Formula IIIc1-3: Formula IIIc1-3 or a pharmaceutically acceptable salt thereof.
  • a compound comprising the structure of Formula IIId: Formula IIId or a pharmaceutically acceptable salt thereof.
  • a hydrate of the compound of Formula IIIc or Formula IIId include (compound of Formula IIIc or Formula IIId • ZH2O), wherein Z is from 1 to 50.
  • Z is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50.
  • Z is between any two of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 and 50.
  • Ratios of Counterion(s) to Ionic Salt Form of Semaglutide [00264]
  • WSGR Docket No.: 56017-729.601 (i) a weight % (wt. %) ratio of : is from about 0.1 wt. %: 99.9 wt. % to about 20.0 wt. %: 80.0 wt.
  • a weight % (wt. %) ratio of any combination thereof is from about 0.1 wt. %: 99.9 wt. % to about 20.0 wt. %: 80.0 wt. %.
  • a molar ratio of : is from about 2:1 to about 10:1; or (ii) a molar ratio of any combination thereof is from about 2:1 to about 10:1.
  • a molar ratio of : is from about 2:1 to about 7:1; or (ii) a molar ratio any combination thereof is from about 2:1 to about 7:1.
  • a molar ratio of : is from about 3:1 to about 7:1; or (ii) a molar ratio any combination thereof is from about 3:1 to about 7:1.
  • WSGR Docket No.: 56017-729.601 (i) a molar ratio of : is from about 4:1 to about 7:1; or (ii) a molar ratio of any combination thereof is from about 4:1 to about 7:1.
  • a molar ratio of : is from about 3:1 to about 7:1; or (ii) a molar ratio of any combination thereof is about 4:1.
  • a weight % (wt. %) ratio of : is from about 0.1 wt. %: 99.9 wt. % to about 20.0 wt. %: 80.0 wt. %.
  • a weight % (wt. %) ratio of : is from about 0.2 wt. %: 99.8 wt. %, from about 0.3 wt. %: 99.7 wt. %, from about 0.4 wt. %: 99.6 wt. %, from about 0.5 wt. %: 99.5 wt.
  • wt. % from about 0.6 wt. %: 99.4 wt. %, from about 0.7 wt. %: 99.3 wt. %, from about 0.8 wt. %: 99.2 wt. %, from about 0.9 wt. %: 99.1 wt. %, from about 1.0 wt. %: 99.0 wt. %, from about 1.1 wt. %: 98.9 wt. %, from about 1.2 wt. %: 98.8 wt. %, from about 1.3 wt. %: 98.7 wt. %, from about 1.4 wt.
  • wt. % from about 15 wt. %: 85 wt. %, from about 16 wt. %: 84 wt. %, from about 17 wt. %: 83 wt. %, from about 18 wt. %: 82 WSGR Docket No.: 56017-729.601 wt. %, from about 19 wt. %: 81 wt. %, from about 20 wt. %: 80 wt. %, from about 21 wt. %: 79 wt. %, from about 22 wt. %: 78 wt. %, from about 23 wt. %: 77 wt.
  • a weight % (wt. %) ratio of : is to about 20.0 wt. %: 80.0 wt. %. In some embodiments, a weight % (wt. %) ratio of : is to about 0.2 wt. %: 99.8 wt. %, to about 0.3 wt. %: 99.7 wt. %, to about 0.4 wt. %: 99.6 wt. %, to about 0.5 wt. %: 99.5 wt. %, to about 0.6 wt. %: 99.4 wt. %, to about 0.7 wt. %: 99.3 wt.
  • wt. % 98.1 wt. %, to about 2.0 wt. %: 98.0 wt. %, to about 3.0 wt. %: 97.0 wt. %, to about 4.0 wt. %: 96.0 wt. %, to about 5.0 wt. %: 95.0 wt. %, to about 6.0 wt. %: 94.0 wt. %, to about 7.0 wt. %: 93.0 wt.
  • a weight % (wt. %) ratio of : is from about 0.2 wt. %: WSGR Docket No.: 56017-729.601 99.8 wt. % to about 95 wt. %: 5 wt. % , from about 0.3 wt.
  • a weight % (wt. %) ratio of : is from about 0.1 wt. %: 99.9 wt. % to about 0.2 wt. %: 99.8 wt. %, from about 0.1 wt. %: 99.9 wt. % to about 0.3 wt. %: 99.7 wt. %, from about 0.1 wt. %: 99.9 wt. % to about 0.4 wt.
  • a weight % (wt. %) ratio of : is from about 0.1 wt. %: 99.9 wt. % to about 95 wt. %: 5 wt. %, from about 0.2 wt. %: 99.8 wt. % to about 90 wt. %: 10 wt. %, from about 0.3 wt. %: 99.7 wt. % to about 85 wt. %: 15 wt. %, from about 0.4 wt.
  • a weight % (wt. %) ratio of : is about 0.1 wt. %: 99.9 wt. %, about 0.2 wt. %: 99.8 wt. %, about 0.3 wt. %: 99.7 wt. %, about 0.4 wt. %: 99.6 wt.
  • wt. % about 0.5 wt. %: 99.5 wt. %, about 0.6 wt. %: 99.4 wt. %, about 0.7 wt. %: 99.3 wt. %, about 0.8 WSGR Docket No.: 56017-729.601 wt. %: 99.2 wt. %, about 0.9 wt. %: 99.1 wt. %, about 1.0 wt. %: 99.0 wt. %, about 1.1 wt. %: 98.9 wt. %, about 1.2 wt. %: 98.8 wt. %, about 1.3 wt.
  • wt. % about 5.0 wt. %: 95.0 wt. %, about 6.0 wt. %: 94.0 wt. %, about 7.0 wt. %: 93.0 wt. %, about 8.0 wt. %: 92.0 wt. %, about 9.0 wt. %: 91.0 wt. %, about 10 wt. %: 90 wt. %, about 11 wt. %: 89 wt. %, about 12 wt. %: 88 wt. %, about 13 wt. %: 87 wt. %, about 14 wt. %: 86 wt.
  • wt. % about 15 wt. %: 85 wt. %, about 16 wt. %: 84 wt. %, about 17 wt. %: 83 wt. %, about 18 wt. %: 82 wt. %, about 19 wt. %: 81 wt. %, about 20 wt. %: 80 wt. %, about 21 wt. %: 79 wt. %, about 22 wt. %: 78 wt. %, about 23 wt. %: 77 wt. %, about 24 wt. %: 76 wt. %, about 25 wt.
  • % 75 wt. %, about 26 wt. %: 74 wt. %, about 27 wt. %: 73 wt. %, about 28 wt. %: 72 wt. %, about 29 wt. %: 71 wt. %, about 30 wt. %: 70 wt. %, about 35 wt. %: 65 wt. %, about 40 wt. %: 60 wt. %, about 45 wt. %: 55 wt. %, about 50 wt. %: 50 wt. %, about 55 wt. %: 45 wt. %, about 60 wt.
  • a weight % (wt. %) ratio of : , , or any combination thereof is from about 0.1 wt. %: 99.9 wt.
  • a weight % (wt. %) ratio of : , , or any combination thereof is from about 0.2 wt. %: 99.8 wt. %, from about 0.3 wt. %: 99.7 wt. %, from about 0.4 wt. %: 99.6 wt. %, from about 0.5 wt. %: 99.5 wt. %, from about 0.6 wt. %: 99.4 wt. %, from about 0.7 wt. %: 99.3 wt. %, from about 0.8 wt.
  • a weight % (wt. %) ratio of : , , or any combination thereof is from about 0.2 wt. %: 99.8 wt. % to about 95 wt. %: 5 wt. % , from about 0.3 wt. %: 99.7 wt. % to about 95 wt. %: 5 wt. %, from about 0.4 wt. %: 99.6 wt. % to about 95 wt. %: 5 wt. %, from about 0.5 wt. %: 99.5 wt. % to about 95 wt.
  • a weight % (wt. %) ratio of : , , or any combination thereof is from about 0.1 wt.
  • a weight % (wt.
  • ratio of , , or any combination thereof is from about 0.1 wt. %: 99.9 wt. % to about 95 wt. %: 5 wt. %, from about 0.2 wt. %: 99.8 wt. % to about 90 wt. %: 10 wt. %, from about 0.3 wt. %: 99.7 wt. % to about 85 wt. %: 15 wt. %, from about 0.4 wt. %: 99.6 wt. % to about 80 wt. %: 20 wt. %, from about 0.5 wt. %: 99.5 wt. % to about 75 wt.
  • % 50 wt. %, from about 1.1 wt. %: 98.9 wt. % to about 45 wt. %: 55 wt. %, from about 1.2 wt. %: 98.8 wt. % to about 40 wt. %: 60 wt. %, from about 1.3 wt. %: 98.7 wt. % to about 35 wt. %: 65 wt. %, from about 1.4 wt. %: 98.6 wt. % to about 30 wt. %: 70 wt. %, from about 1.5 wt. %: 98.5 wt. % to about 29 wt.
  • wt. % about 0.7 wt. %: 99.3 wt. %, about 0.8 wt. %: 99.2 wt. %, about 0.9 wt. %: 99.1 wt. %, about 1.0 wt. %: 99.0 wt. %, about 1.1 wt. %: 98.9 wt. %, about 1.2 wt. %: 98.8 wt. %, about 1.3 wt. %: 98.7 wt. %, about 1.4 wt. %: 98.6 wt. %, about 1.5 wt. %: 98.5 wt. %, about 1.6 wt.
  • wt. % about 8.0 wt. %: 92.0 wt. %, about 9.0 wt. %: 91.0 wt. %, about 10 wt. %: 90 wt. %, about 11 wt. %: 89 wt. %, about 12 wt. %: 88 wt. %, about 13 wt. %: 87 wt. %, about 14 wt. %: 86 wt. %, about 15 wt. %: 85 wt. %, about 16 wt. %: 84 wt. %, about 17 wt. %: 83 wt. %, about 18 wt.
  • a molar ratio of : is from about 2:1 to about 10:1, or any ratio between any two of these values. In some embodiments, a molar ratio of : is from about 2:1 to about 7:1, or any ratio between any two of these values. In some embodiments, a molar ratio of : is from about 3:1 to about 7:1, or any ratio between any two of these values.
  • a molar ratio of : is to about 1:2, to about 1:3, to about 1:4, to about 1:5, to about 1:6, to about 1:7, to about 1:8, to about 1:9, to about 1:10, to about 1:11, to about 1:12, to about 1:13, to about 1:14, to about 1:15, to about 1:16, to about 1:17, to about 1:18, to about 1:19, to about 1:20, to about 1:21, to about 1:22, to about 1:23, to about 1:24, to about 1:25, to about 1:26, to about 1:27, to about 1:28, to about 1:29, or to about 1:30, or any ratio between any two of these values.
  • a molar ratio of : is from about 1:1 to about 1:2, from about 1:1 to about 1:3, from about 1:1 to about 1:4, from about 1:1 to about 1:5, from about 1:1 to about 1:6, from about 1:1 to about 1:7, from about 1:1 to about 1:8, from about 1:1 to about 1:9, from about 1:1 to about 1:10, from about 1:1 to about 1:11, from about 1:1 to about 1:12, from about 1:1 to about 1:13, from about 1:1 to about 1:14, from about 1:1 to about 1:15, from about 1:1 to about 1:16, from about 1:1 to about 1:17, from about 1:1 to about 1:18, from about 1:1 to about 1:19, from about 1:1 to about 1:20, from about 1:1 to about 1:21, from about 1:1 to WSGR Docket No.: 56017-729.601 about 1:22, from about 1:1 to about 1:23, from about 1:1 to about 1:24, from about 1:1 to about 1:25, from about 1:1 to about 1:26, from about 1:1 to about 1:27, from about 1:1 to about 1:28, from about 1:1 to about 1:29, or from about 1:1 to about 1:1
  • a molar ratio of : is from about 1:1 to about 1:30, from about 1:2 to about 1:30, from about 1:3 to about 1:30, from about 1:4 to about 1:30, from about 1:5 to about 1:30, from about 1:6 to about 1:30, from about 1:7 to about 1:30, from about 1:8 to about 1:30, from about 1:9 to about 1:30, from about 1:10 to about 1:30, from about 1:11 to about 1:30, from about 1:12 to about 1:30, from about 1:13 to about 1:30, from about 1:14 to about 1:30, from about 1:15 to about 1:30, from about 1:16 to about 1:30, from about 1:17 to about 1:30, from about 1:18 to about 1:30, from about 1:19 to about 1:30, from about 1:20 to about 1:30, from about 1:21 to about 1:30, from about 1:22 to about 1:30, from about 1:23 to about 1:30, from about 1:24 to about 1:30, from about 1:25 to about 1:30, from about 1:
  • a molar ratio of : is from about 1:1 to about 2:1, from about 1:1 to about 3:1, from about 1:1 to about 4:1, from about 1:1 to about 5:1, from about 1:1 to about 6:1, from about 1:1 to about 7:1, from about 1:1 to about 8:1, from about 1:1 to about 9:1, from about 1:1 to about 10:1, from about 1:1 to about 11:1, from about 1:1 to about 12:1, from about 1:1 to about 13:1, from about 1:1 to about 14:1, from about 1:1 to about 15:1, from about 1:1 to about 16:1, from about 1:1 to about 17:1, from about 1:1 to about 18:1, from about 1:1 to about 19:1, from about 1:1 to about 20:1, from about 1:1 to about 21:1, from about 1:1 to about 22:1, from about 1:1 to about 23:1, from about 1:1 to about 24:1, from about 1:1 to about 25:1, from about 1:1 to about 26:1, from about 1:1 to about 27:1, from about 1:1 to about 28:1, from about 1:1 to about 29:1, or from about 1:1 to about 30:1, or any ratio between any ratio between any ratio between any ratio between any
  • a molar ratio of : is from about 1:1 to about 30:1, from about 2:1 to about 30:1, from about 3:1 to about 30:1, from about 4:1 to about 30:1, from about 5:1 to about 30:1, from about 6:1 to about 30:1, from about 7:1 to about 30:1, from about 8:1 to about 30:1, from about 9:1 to about 30:1, from about 10:1 to about 30:1, from about 11:1 to about 30:1, from about 12:1 to about 30:1, from about 13:1 to about 30:1, from about 14:1 to about 30:1, WSGR Docket No.: 56017-729.601 from about 15:1 to about 30:1, from about 16:1 to about 30:1, from about 17:1 to about 30:1, from about 18:1 to about 30:1, from about 19:1 to about 30:1, from about 20:1 to about 30:1, from about 21:1 to about 30:1, from about 22:1 to about 30:1, from about 23:1 to
  • a molar ratio of : is from about 1:1 to about 10:1, from about 2:1 to about 10:1, from about 3:1 to about 10:1, from about 4:1 to about 10:1, from about 5:1 to about 10:1, from about 6:1 to about 10:1, from about 7:1 to about 10:1, from about 8:1 to about 10:1, or from about 9:1 to about 10:1, or any ratio between any two of these values.
  • a molar ratio of : is from about 1:1 to about 10:1, from about 1:1 to about 9:1, from about 1:1 to about 8:1, from about 1:1 to about 7:1, from about 1:1 to about 6:1, from about 1:1 to about 5:1, from about 1:1 to about 4:1, from about 1:1 to about 3:1, or from about 1:1 to about 2:1, or any ratio between any two of these values. [00294] In some embodiments, a molar ratio of : is from about 1:1 to about 7:1, from about 2:1 to about 7:1, from about 3:1 to about 7:1, from about 4:1 to about 7:1, from about 5:1 to about 7:1, or from about 6:1 to about 7:1, or any ratio between any two of these values.
  • a molar ratio of : is from about 1:1 to about 7:1, from about 1:1 to about 6:1, from about 1:1 to about 5:1, from about 1:1 to about 4:1, from about 1:1 to about 3:1, or from about 1:1 to about 2:1, or any ratio between any two of these values.
  • a molar ratio of : is about 1:1, about 2:1, about 3:1, about 4:1, about 5:1, about 6:1, about 7:1, about 8:1, about 9:1, about 10:1, about 11:1, about 12:1, about 13:1, about 14:1, about 15:1, about 16:1, about 17:1, about 18:1, about 19:1, about 20:1, WSGR Docket No.: 56017-729.601 about 21:1, about 22:1, about 23:1, about 24:1, about 25:1, about 26:1, about 27:1, about 28:1, about 29:1, or about 30:1, or any ratio between any two of these values.
  • a molar ratio of : is from about 1:1 to about 1:7. In some embodiments, a molar ratio of : is from about 1:2 to about 1:7. In some embodiments, a molar ratio of : is from about 1:3 to about 1:7. In some embodiments, a molar ratio of : is from about 1:4 to about 1:7. In some embodiments, a molar ratio of : is from about 1:5 to about 1:7. In some embodiments, a molar ratio of is from about 1:6 to about 1:7. In some embodiments, a molar ratio : is from about 1:1 to about 1:6.
  • a molar ratio of : is from about 1:1 to about 1:5. In some embodiments, a molar ratio of : is from about 1:1 to about 1:4. In some embodiments, a molar ratio of : is from about 1:1 to about 1:3. In some embodiments, a molar ratio of : is from about 1:1 to about 1:2. In some embodiments, a molar ratio : is from about 1:2 to about 1:7. In some embodiments, a molar ratio of is from about 1:2 to about 1:6. In some embodiments, a molar ratio : is from about 1:2 to about 1:5. In some embodiments, a molar ratio : is from about 1:2 to about 1:4.
  • a molar ratio of : is from about 1:4 to about 1:5. In some embodiments, a molar ratio of : is from about 1:5 to about 1:7. In some embodiments, a molar ratio of : is from about 1:5 to about 1:6. In some embodiments, a molar ratio of is about 1:2. In some embodiments, a molar ratio of : is about 1:3. In some embodiments, a molar ratio some embodiments, a molar ratio of : is about 1:6. In some embodiments, a molar ratio about 1:7. [00298] In some embodiments, a molar ratio of any combination thereof is from about 2:1 to about 10:1.
  • a molar ratio of : WSGR Docket No.: 56017-729.601 , , , or any combination thereof is from about 2:1 to about 7:1. In some embodiments, a molar ratio any combination thereof is from about 3:1 to about 7:1. In some embodiments, a molar ratio of : , , or any combination thereof is from about 4:1 to about 7:1. In some embodiments, a molar ratio any combination thereof is about 4:1.
  • a molar ratio of , or any combination thereof is from about 1:1, from about 1:2, from about 1:3, from about 1:4, from about 1:5, from about 1:6, from about 1:7, from about 1:8, from about 1:9, from about 1:10, from about 1:11, from about 1:12, from about 1:13, from about 1:14, from about 1:15, from about 1:16, from about 1:17, from about 1:18, from about 1:19, from about 1:20, from about 1:21, from about 1:22, from about 1:23, from about 1:24, from about 1:25, from about 1:26, from about 1:27, from about 1:28, from about 1:29, or from about 1:30, or any ratio between any two of these values.
  • a molar ratio any combination thereof is from about 1:1, from about 2:1, from about 3:1, from about 4:1, from about 5:1, from about 6:1, from about 7:1, from about 8:1, from about 9:1, from about 10:1, from about 11:1, from about 12:1, from about 13:1, from about 14:1, from about 15:1, from about 16:1, from about 17:1, from about 18:1, from about 19:1, from about 20:1, from about 21:1, from about 22:1, from about 23:1, from about 24:1, from about 25:1, from about 26:1, from about 27:1, from about 28:1, or from about 29:1, from about 30:1, or any ratio between any two of these values.
  • a molar ratio of , or any combination thereof is to about 1:2, to about 1:3, to about 1:4, to about 1:5, to about 1:6, to about 1:7, to about 1:8, to about 1:9, to about 1:10, to about 1:11, to about 1:12, to about 1:13, to about 1:14, to about 1:15, to about 1:16, to about 1:17, to about 1:18, to about 1:19, to about 1:20, to about 1:21, to about 1:22, to about 1:23, to about 1:24, to about 1:25, to about 1:26, to about 1:27, to about 1:28, to about 1:29, or to about 1:30, or any ratio between any two of these values.
  • a molar ratio of , or any combination thereof is to about 1:1, to about 2:1, to about 3:1, to about 4:1, to about 5:1, to about 6:1, to about 7:1, to about 8:1, to about 9:1, to about 10:1, to about 11:1, to about 12:1, to about 13:1, to about 14:1, to about 15:1, to about 16:1, to about 17:1, to about 18:1, to about 19:1, to about 20:1, to about 21:1, to about 22:1, to about 23:1, to about 24:1, to about 25:1, to about 26:1, to about 27:1, to about 28:1, to about 29:1, or to about 30:1, or any ratio between any two of these values.
  • a molar ratio of , or any combination thereof is from about 1:1 to about 1:2, from about 1:1 to about 1:3, from about 1:1 to WSGR Docket No.: 56017-729.601 about 1:4, from about 1:1 to about 1:5, from about 1:1 to about 1:6, from about 1:1 to about 1:7, from about 1:1 to about 1:8, from about 1:1 to about 1:9, from about 1:1 to about 1:10, from about 1:1 to about 1:11, from about 1:1 to about 1:12, from about 1:1 to about 1:13, from about 1:1 to about 1:14, from about 1:1 to about 1:15, from about 1:1 to about 1:16, from about 1:1 to about 1:17, from about 1:1 to about 1:18, from about 1:1 to about 1:19, from about 1:1 to about 1:20, from about 1:1 to about 1:21, from about 1:1 to about 1:22, from about 1:1 to about 1:23, from about 1:1 to about 1:24, from about 1:1 to about 1:25, from about 1:1 to about 1:26, from about 1:1 to about 1:27, from about 1:1 to about 1:28, from about 1:1 to about 1:29, or
  • a molar ratio of , or any combination thereof is from about 1:1 to about 1:30, from about 1:2 to about 1:30, from about 1:3 to about 1:30, from about 1:4 to about 1:30, from about 1:5 to about 1:30, from about 1:6 to about 1:30, from about 1:7 to about 1:30, from about 1:8 to about 1:30, from about 1:9 to about 1:30, from about 1:10 to about 1:30, from about 1:11 to about 1:30, from about 1:12 to about 1:30, from about 1:13 to about 1:30, from about 1:14 to about 1:30, from about 1:15 to about 1:30, from about 1:16 to about 1:30, from about 1:17 to about 1:30, from about 1:18 to about 1:30, from about 1:19 to about 1:30, from about 1:20 to about 1:30, from about 1:21 to about 1:30, from about 1:22 to about 1:30, from about 1:23 to about 1:30, from about 1:24 to about 1:30, from about 1:25 to about 1:30,
  • a molar ratio any combination thereof is from about 1:1 to about 2:1, from about 1:1 to about 3:1, from about 1:1 to about 4:1, from about 1:1 to about 5:1, from about 1:1 to about 6:1, from about 1:1 to about 7:1, from about 1:1 to about 8:1, from about 1:1 to about 9:1, from about 1:1 to about 10:1, from about 1:1 to about 11:1, from about 1:1 to about 12:1, from about 1:1 to about 13:1, from about 1:1 to about 14:1, from about 1:1 to about 15:1, from about 1:1 to about 16:1, from about 1:1 to about 17:1, from about 1:1 to about 18:1, from about 1:1 to about 19:1, from about 1:1 to about 20:1, from about 1:1 to about 21:1, from about 1:1 to about 22:1, from about 1:1 to about 23:1, from WSGR Docket No.: 56017-729.601 about 1:1 to about 24:1, from about 1:1 to about 25:1, from about 1:1 to about 26:1, from about 1:1 to about 27:1, from about 1:1 to about 28:1, from about 1:1 to about 29
  • a molar ratio any combination thereof is from about 1:1 to about 30:1, from about 2:1 to about 30:1, from about 3:1 to about 30:1, from about 4:1 to about 30:1, from about 5:1 to about 30:1, from about 6:1 to about 30:1, from about 7:1 to about 30:1, from about 8:1 to about 30:1, from about 9:1 to about 30:1, from about 10:1 to about 30:1, from about 11:1 to about 30:1, from about 12:1 to about 30:1, from about 13:1 to about 30:1, from about 14:1 to about 30:1, from about 15:1 to about 30:1, from about 16:1 to about 30:1, from about 17:1 to about 30:1, from about 18:1 to about 30:1, from about 19:1 to about 30:1, from about 20:1 to about 30:1, from about 21:1 to about 30:1, from about 22:1 to about 30:1, from about 23:1 to about 30:1, from about 24:1 to about 30:1, from about 25
  • a molar ratio combination thereof is from about 1:1 to about 10:1, from about 2:1 to about 10:1, from about 3:1 to about 10:1, from about 4:1 to about 10:1, from about 5:1 to about 10:1, from about 6:1 to about 10:1, from about 7:1 to about 10:1, from about 8:1 to about 10:1, or from about 9:1 to about 10:1.
  • a molar ratio of , or any combination thereof is from about 1:1 to about 10:1, from about 1:1 to about 9:1, from about 1:1 to about 8:1, from about 1:1 to about 7:1, from about 1:1 to about 6:1, from about 1:1 to about 5:1, from about 1:1 to about 4:1, from about 1:1 to about 3:1, or from about 1:1 to about 2:1.
  • a molar ratio any combination thereof is from about 1:1 to about 7:1, from about 2:1 to about 7:1, from about 3:1 to about 7:1, from about 4:1 to about 7:1, from about 5:1 to about 7:1, or from about 6:1 to about 7:1.
  • a molar ratio of : , or any combination thereof is from about 1:1 to about 7:1, from about 1:1 to about 6:1, from about 1:1 to about 5:1, from about 1:1 to about 4:1, from about 1:1 to about 3:1, or from about 1:1 to about 2:1.
  • a molar ratio of , or any combination thereof is about 1:1 , about 1:2, about 1:3, about 1:4, about 1:5, about 1:6, about 1:7, about 1:8, about 1:9, about 1:10, about 1:11, about 1:12, about 1:13, about 1:14, about 1:15, about 1:16, about 1:17, about 1:18, about 1:19, about 1:20, about 1:21, about 1:22, about 1:23, about 1:24, about 1:25, about 1:26, about 1:27, about 1:28, about 1:29, or about 1:30, or any ratio between any two of these values.
  • a molar ratio of , or any combination thereof is about 1:1, about 2:1, about 3:1, about 4:1, about 5:1, about 6:1, about 7:1, about 8:1, about 9:1, about 10:1, about 11:1, about 12:1, about 13:1, about 14:1, about 15:1, about 16:1, about 17:1, about 18:1, about 19:1, about 20:1, about 21:1, about 22:1, about 23:1, about 24:1, about 25:1, about 26:1, about 27:1, about 28:1, about 29:1, or about 30:1, or any ratio between any two of these values.
  • a molar ratio of , , , or any combination thereof: is about 1:1 to about 1:4. In some embodiments, a molar ratio of , , or any combination thereof: is from about 1:2 to about 1:4. In some embodiments, a molar ratio of , , , or any combination thereof: is from about 1:3 to about 1:4. In some embodiments, a molar ratio of , , , , thereof: is from about 1:1 to about 1:2. In some embodiments, a molar ratio of , is from about 1:2 to about 1:4.
  • a molar ratio of , , , or any combination thereof: is from about 1:2 to about 1:3. In some embodiments, a molar ratio of , is from about 1:3 to about 1:4. In some embodiments, a molar ratio of , , , or any combination thereof: is about 1:1. In some embodiments, a molar ratio of , embodiments, a molar ratio any combination thereof: is about 1:4.
  • GLP-1 receptor agonists [00312] In some embodiments, the therapeutic agent is a GLP-l receptor agonist or a functional variant thereof.
  • the GLP-1 receptor agonist is a polypeptide having an amino acid sequence similar to the GLP-1 hormone.
  • the GLP-1 receptor agonist comprises one or more chemical modifications that are different from endogenous GLP- 1.
  • the one or more chemical modifications render the GLP-1 receptor agonist superior therapeutic effects compared with endogenous GLP-1.
  • the GLP-1 receptor agonist comprise a sequence having at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%.
  • the GLP-1 receptor agonist comprise the endogenous GLP-1 sequence (e.g., SEQ ID NO: 1 or SEQ ID NO: 2).
  • the GLP-1 receptor agonist comprising the substitution of an alanine at position 8 of the endogenous GLP-1 sequence (SEQ ID NO: 1 or SEQ ID NO: 2) replaced with 2-aminoisobuteric acid exhibits an enhanced metabolic stability compared with endogenous GLP-1.
  • the GLP-1 receptor agonist comprising the substitution of an alanine at position 8 of the endogenous GLP-1 sequence (SEQ ID NO: 1 or SEQ ID NO: 2) replaced with 2-aminoisobuteric acid exhibits resistance to the breakdown by endogenous enzymes, such as dipeptidyl peptidase-IV.
  • the GLP-1 receptor agonist comprises a sequence having at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%.97%, 98%, 99%, 99.1%, 99.2%, 99.3%, 99.4%, 99.5%, 99.6%, 99.7%, 99.8%, 99.9%, or 100% sequence identity to the sequence of SEQ ID NO: 5.
  • the GLP-1 receptor agonist comprises the sequence of SEQ ID NO: 5.
  • semaglutide comprises the sequence of SEQ ID NO: 5.
  • the compounds as provided herein e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 50.0 wt. % counterion relative to 99.9 wt. % to 50.0 wt. % a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.5 wt. % to 2.0 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt. % to 4.5 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a WSGR Docket No.: 56017-729.601 functional variant thereof from 5.5 wt. % to 6.0 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.5 wt. % to 8.0 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt. % to 9.5 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt. % to 20.0 wt. % salt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt. % to 40.0 wt. % salt.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of a counterion to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium (i.e., NH4 + ) salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, comprises an NMe4 + salt of a GLP-l receptor WSGR Docket No.: 56017-729.601 agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % aluminum cation relative to 99.9 wt. % to 50.0 wt. % a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP- l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of aluminum salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 1.5 wt. % to 2.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.0 wt. % to 2.5 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • WSGR Docket No.: 56017-729.601 are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.5 wt. % to 4.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of aluminum salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 4.0 wt. % to 4.5 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.0 wt. % to 5.5 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of aluminum salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 6.5 wt. % to 7.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.5 wt. % to 8.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.0 wt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt. % to 10.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt.
  • certain aluminum salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain aluminum salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of aluminum salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 30.0 wt. % to 40.0 wt. % aluminum salt.
  • certain aluminum salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of aluminum salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % aluminum salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % sodium cation relative to 99.9 wt. % to 50.0 wt. % a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt.
  • certain sodium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % sodium salt.
  • certain WSGR Docket No.: 56017-729.601 sodium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of sodium salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 1.5 wt. % to 2.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.0 wt. % to 2.5 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.5 wt. % to 4.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of sodium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • wt. % ratios of sodium salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 5.5 wt. % to 6.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.5 wt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a WSGR Docket No.: 56017-729.601 functional variant thereof from 7.0 wt. % to 7.5 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt.
  • % ratios of sodium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.0 wt. % to 8.5 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt. % to 10.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of sodium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • wt. % ratios of sodium salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 15.0 wt. % to 20.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % sodium salt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt.
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain sodium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of sodium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % sodium salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % lithium cation relative to 99.9 wt. % to 50.0 wt. % a GLP-l WSGR Docket No.: 56017-729.601 receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l WSGR Docket No.: 56017-729.601 receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of lithium salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 1.5 wt. % to 2.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.0 wt. % to 2.5 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.5 wt. % to 4.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of lithium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • WSGR Docket No.: 56017-729.601 are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt. % to 6.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.5 wt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of lithium salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 7.5 wt. % to 8.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.0 wt. % to 8.5 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt. % to 10.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of lithium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt. % to 20.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % lithium salt.
  • WSGR Docket No.: 56017-729.601 certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of lithium salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 30.0 wt. % to 40.0 wt. % lithium salt.
  • certain lithium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of lithium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % lithium salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % potassium cation relative to 99.9 wt. % to 50.0 wt. % a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP- l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of potassium salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • wt. % ratios of potassium salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 2.0 wt. % to 2.5 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or WSGR Docket No.: 56017-729.601 a functional variant thereof from 3.5 wt. % to 4.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt.
  • % ratios of potassium salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.0 wt. % to 5.5 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt.
  • % ratios of potassium salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.5 wt. % to 8.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.0 wt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of potassium salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt. % to 10.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt.
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % potassium salt.
  • certain potassium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of potassium salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain potassium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of potassium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % potassium salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % calcium cation relative to 99.9 wt. % to 50.0 wt. % a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof WSGR Docket No.: 56017-729.601 are formulated in wt.
  • % ratios of calcium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.0 wt. % to 2.5 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.5 wt. % to 4.0 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of calcium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt. % to 6.0 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.5 wt.
  • certain calcium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % calcium salt.
  • certain WSGR Docket No.: 56017-729.601 calcium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of calcium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.0 wt. % to 8.5 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt. % to 10.0 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of calcium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt. % to 20.0 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % calcium salt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt.
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain calcium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of calcium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % calcium salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % magnesium cation relative to 99.9 wt. % to 50.0 wt. % a WSGR Docket No.: 56017-729.601 GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % magnesium cation relative to 99.9 wt. % to 5
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of magnesium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.0 wt. % to 2.5 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.5 wt. % to 4.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of magnesium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt. % to 6.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.5 wt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of magnesium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.0 wt. % to 8.5 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt. % to 10.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of magnesium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from WSGR Docket No.: 56017-729.601 15.0 wt. % to 20.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % magnesium salt.
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt.
  • magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain magnesium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of magnesium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % magnesium salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % zinc cation relative to 99.9 wt. % to 50.0 wt. % a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of zinc salt to a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • wt. % ratios of zinc salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.0 wt. % to 2.5 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.5 wt. % to 4.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of zinc salt to a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.0 wt. % to 5.5 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of zinc salt to a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • wt. % ratios of zinc salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.5 wt. % to 8.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.0 wt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • certain zinc salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt. % to 10.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt.
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % zinc salt.
  • certain zinc salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of zinc salt to a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain zinc salt forms of a GLP-l receptor agonist e.g., semaglutide
  • wt. % ratios of zinc salt to a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of zinc salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % zinc salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % ammonium cation relative to 99.9 wt. % to 50.0 wt. % a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor WSGR Docket No.: 56017-729.601 agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.5 wt. % to 2.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt. % to 4.5 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt. % to 6.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., WSGR Docket No.: 56017-729.601 semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.5 wt. % to 8.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt. % to 9.5 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt. % to 20.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of ammonium salt to a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt. % to 40.0 wt. % ammonium salt.
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of ammonium salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % ammonium salt.
  • the compound as provided herein e.g., the salt form of a GLP-l WSGR Docket No.: 56017-729.601 receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % NMe4 + cation relative to 99.9 wt. % to 50.0 wt. % a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • certain ammonium salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.1 wt. % to 0.5 wt. % NMe4+ salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 1.5 wt. % to 2.0 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % NMe4+ salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 3.0 wt. % to 3.5 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt. % to 4.5 wt. % NMe4 + salt.
  • certain NMe 4+ salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant WSGR Docket No.: 56017-729.601 thereof are formulated in wt.
  • NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt. % to 6.0 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 6.0 wt. % to 7.5 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 salt forms of a GLP-l receptor agonist e.g., semaglutide or a functional variant thereof are formulated in wt.
  • NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4+ salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 9.0 wt. % to 9.5 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % NMe 4+ salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 15.0 wt. % to 20.0 wt. % NMe4 + salt.
  • WSGR Docket No.: 56017-729.601 certain NMe4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • NMe 4+ salt a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt. % to 40.0 wt. % NMe4 + salt.
  • certain NMe4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of NMe4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % NMe4 + salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % N(C1–4alkyl)4 + cation relative to 99.9 wt. % to 50.0 wt. % a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide or a functional variant thereof are formulated in wt.
  • N(C1– 4alkyl)4 + salt a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 0.5 wt. % to 1.0 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt.
  • N(C1–4alkyl)4 + salt % N(C1–4alkyl)4 + salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.5 wt. % to 2.0 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP- l receptor agonist e.g., semaglutide or a functional variant thereof are formulated in wt.
  • N(C1–4alkyl)4 + salt % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • WSGR Docket No.: 56017-729.601 are formulated in wt.
  • N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt. % N(C1–4alkyl) 4+ salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.5 wt.
  • N(C1–4alkyl)4 + salt forms of a GLP- l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP- l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof e.g., semaglutide
  • certain N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide or a functional variant thereof are formulated in wt.
  • N(C1–4alkyl)4 + salt a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.0 wt. % to 5.5 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt.
  • N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP- l receptor agonist e.g., semaglutide or a functional variant thereof are formulated in wt.
  • N(C1–4alkyl)4 + salt a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.5 wt.
  • N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 8.0 wt. % to WSGR Docket No.: 56017-729.601 8.5 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP- l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide or a functional variant thereof are formulated in wt.
  • N(C1–4alkyl)4 + salt a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt. % to 9.5 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.5 wt.
  • N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide or a functional variant thereof are formulated in wt.
  • N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 20.0 wt. % to 30.0 wt. % N(C1–4alkyl)4 + salt.
  • certain N(C1–4alkyl)4 + salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt.
  • N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain N(C1– 4alkyl)4 + salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of N(C1–4alkyl)4 + salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % N(C1–4alkyl)4 + salt.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a wt. % ratio of from 0.1 wt. % to 50.0 wt. % amine cation relative to 99.9 wt. % to 50.0 wt. % a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP- l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof from 0.1 wt. % to 0.5 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.0 wt. % to 1.5 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 1.5 wt. % to 2.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 2.5 wt. % to 3.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 3.0 wt. % to 3.5 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.0 wt. % to 4.5 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 4.5 wt. % to 5.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 5.5 wt. % to 6.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 6.0 wt. % to 7.5 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.0 wt. % to 7.5 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 7.5 wt. % to 8.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 8.5 wt. % to 9.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 9.0 wt. % to 9.5 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 10.0 wt. % to 15.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP- l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 15.0 wt. % to 20.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt.
  • % ratios of amine cation salt to a GLP-l receptor agonist e.g., semaglutide
  • a GLP-l receptor agonist e.g., semaglutide
  • certain WSGR Docket No.: 56017-729.601 amine cation salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 30.0 wt. % to 40.0 wt. % amine cation salt.
  • certain amine cation salt forms of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in wt. % ratios of amine cation salt to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof from 40.0 wt. % to 50.0 wt. % amine cation salt.
  • the compounds as provided herein e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 1:1 to 20:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 1:1 to 15:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 1:1 to 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 2:1 to 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 3:1 to 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 4:1 to 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 5:1 to 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided WSGR Docket No.: 56017-729.601 herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios from 6:1 to 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 1:1 to 2:1 (e.g., 1.2:1, 1.4:11.6:1, 1.8:1, etc.) of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 2:1 to 3:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 3:1 to 4:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 4:1 to 5:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 5:1 to 6:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 6:1 to 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 7:1 to 8:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 8:1 to 9:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 9:1 to 10:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 10:1 to 11:1 of a counterion relative to a GLP-l receptor agonist (e.g., WSGR Docket No.: 56017-729.601 semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof are formulated in molar ratios of from 10:1 to 11:1 of a counterion relative to a GLP-l receptor agonist (e.g., WSGR Docket No.: 56017-729.601 semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 11:1 to 12:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 12:1 to 13:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 13:1 to 14:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 14:1 to 15:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in molar ratios of from 15:1 to 20:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 1:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 2:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein, e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 3:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 4:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 5:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 6:1 of a WSGR Docket No.: 56017-729.601 counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 8:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 9:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of about 10:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of greater than 7:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of from 7:1 to 10:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compounds as provided herein e.g., the salt forms of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof are formulated in a molar ratio of from 10:1 to 20:1 of a counterion relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound WSGR Docket No.: 56017-729.601 as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a WSGR Docket No.: 56017-729.601 functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 6:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an aluminum salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of aluminum cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a WSGR Docket No.: 56017-729.601 functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of sodium cation relative to a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of sodium cation relative to a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof WSGR Docket No.: 56017-729.601 formulated in a molar ratio of from 6:1 to 7:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • WSGR Docket No.: 56017-729.601 formulated in a molar ratio of from 6:1 to 7:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a sodium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of sodium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 1:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 2:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of WSGR Docket No.: 56017-729.601 lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 4:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 5:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 6:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 7:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the WSGR Docket No.: 56017-729.601 compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a lithium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a lithium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of lithium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 1:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 2:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 3:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound WSGR Docket No.: 56017-729.601 as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 5:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 6:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 7:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a potassium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a WSGR Docket No.: 56017-729.601 functional variant thereof comprises a potassium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of potassium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant WSGR Docket No.: 56017-729.601 thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of calcium cation relative to a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of calcium cation relative to a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a calcium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of calcium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of WSGR Docket No.: 56017-729.601 a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 1:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 2:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 3:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 4:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a WSGR Docket No.: 56017-729.601 molar ratio of 5:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a WSGR Docket No.: 56017-729.601 molar ratio of 5:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 6:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 7:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a magnesium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a magnesium salt of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of magnesium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 1:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of WSGR Docket No.: 56017-729.601 from 1:1 to 2:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of 5:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor WSGR Docket No.: 56017-729.601 agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a zinc salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises a zinc salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises a zinc salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of zinc cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor WSGR Docket No.: 56017-729.601 agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the salt form of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor WSGR Docket No.: 56017-729.601 agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 WSGR Docket No.: 56017-729.601 to 7:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an ammonium salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of ammonium cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of NMe4+ cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of NMe4+ cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of WSGR Docket No.: 56017-729.601 NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of WSGR Docket No.: 56017-729.601 NMe4 + cation relative to a GLP-l receptor agonist
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of NMe4+ cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of NMe4+ cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the WSGR Docket No.: 56017-729.601 compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe 4+ salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an NMe4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of NMe4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of N(C1– 4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant WSGR Docket No.: 56017-729.601 thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C 1–4 alkyl) 4+ salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of N(C1– 4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C1–4alkyl)4 + salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the compound WSGR Docket No.: 56017-729.601 as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an N(C 1–4 alkyl) 4+ salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of N(C1–4alkyl)4 + cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the salt form of a GLP-l receptor agonist comprises an N(C 1–4 alkyl) 4+ salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 1:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 1:1 to 2:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 2:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 2:1 to 3:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 3:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 3:1 to 4:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 4:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the WSGR Docket No.: 56017-729.601 compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the salt form of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 4:1 to 5:1 of amine c
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 5:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 5:1 to 6:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 6:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 6:1 to 7:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP- l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of 7:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 7:1 to 10:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof formulated in a molar ratio of from 10:1 to 20:1 of amine cation relative to a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the compound as provided herein e.g., the salt form of a GLP-l WSGR Docket No.: 56017-729.601 receptor agonist (e.g., semaglutide) or a functional variant thereof comprises an amine cation salt of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • Formulations of Salt Forms of Semaglutide [00344]
  • the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of between 3.0 and 8.0.
  • the salt form of a GLP-l receptor agonist e.g., semaglutide
  • a functional variant thereof is formulated to a pH of between 6.0 and 8.0.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.0.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.1.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.2.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.3.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.4.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.5.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.6.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.7.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 6.8.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is WSGR Docket No.: 56017-729.601 formulated to a pH of about 6.9.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.0.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.1.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.2.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.3.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.4.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.5.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.6.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.7.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.8.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 7.9.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of about 8.0.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of from 6.0 to 6.5.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of from 6.5 to 7.0.
  • the compound as provided herein or the composition as provided herein e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of from 7.0 to 7.5.
  • the compound as provided herein or the composition as provided herein, e.g., the compound as provided herein, e.g., the salt form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof is formulated to a pH of from 7.5 to 8.0.
  • the compound as provided herein comprises any stable isotope of any of the elements of the compound as provided herein.
  • any atom not specifically designated as a particular isotope in the compound as provided herein, or any disclosed pharmaceutically acceptable salt thereof, as disclosed herein, is meant to represent any stable isotope of the specified element.
  • stable when referring to an isotope, means that the isotope is not known to undergo spontaneous radioactive decay.
  • exemplary stable isotopes include, but are not limited to, the isotopes for which no decay mode is identified in V. S. Shirley & C. M.
  • H refers to hydrogen and includes any stable isotope of hydrogen. Where an atom is designated as “H,” no effort was made to enrich that atom in a particular isotope of hydrogen, and therefore a person of ordinary skill in the art would understand that such hydrogen atom likely was present at approximately the natural abundance isotopic composition of hydrogen.
  • D deuterium
  • semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof includes one or more atoms having an atomic mass or mass number which differs from the atomic mass or mass number of the most abundant isotope of the specified element WSGR Docket No.: 56017-729.601 (“isotope-labelled” compound as provided herein or pharmaceutically acceptable salt forms thereof).
  • isotope-labelled compound as provided herein or pharmaceutically acceptable salt forms thereof examples include without limitation isotopes of hydrogen, carbon, nitrogen, oxygen, and phosphorus, for example 2H, 13C, 15N, 18O, 17O, and 31P, respectively.
  • the isotope-labelled version of semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein can be used in a number of beneficial ways, including as medicaments.
  • semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein is deuterium (2H)-labelled.
  • deuterium (2H)-labelled semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein is therapeutically useful with potential therapeutic advantages over the non-2H-labelled semaglutide as provided herein.
  • deuterium (2H)-labelled semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein can have higher metabolic stability as compared to the semaglutide that is not isotope-labelled owing to the kinetic isotope effect described below. In some embodiments, higher metabolic stability translates directly into an increased in vivo half- life or lower dosages, which under most circumstances would represent an advantageous embodiment of semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein.
  • the isotope-labelled semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein, can usually be prepared by carrying out the procedures disclosed in known methods for the synthesis of semaglutide by replacing a non-isotope-labelled reactant by a readily available isotope-labelled reactant (see, e.g., U.S. Patent Nos.8,129,343 and 8,536,122, incorporated in its entirety herein by reference).
  • the deuterium (2H)-labelled semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein can manipulate the rate of oxidative metabolism of the compound by way of the primary kinetic isotope effect.
  • the primary kinetic isotope effect is a change of the rate for a chemical reaction that results from exchange of isotopic nuclei, which in turn is caused by the change in ground state energies of the covalent bonds involved in the reaction.
  • exchange of a heavier isotope usually results in a lowering of the ground state energy for a chemical bond and thus causes a reduction in the rate-limiting bond breakage.
  • the bond breakage occurs in or in the vicinity of a saddle-point region along the coordinate of a multi- product reaction, the product distribution ratios can be altered substantially.
  • the concentration of an isotope (e.g., deuterium) incorporated at a given position of an isotope-labelled version of semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein, may be defined by the isotopic enrichment factor.
  • the term “isotopic enrichment factor,” as used herein, means the ratio between the abundance of an isotope at a given position in an isotope-labeled semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein, and the natural abundance of the isotope.
  • an atom in t semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein, is designated as deuterium
  • such compound (or salt) has an isotopic enrichment factor for such atom of at least 3000 (45% deuterium incorporation).
  • the isotopic enrichment factor is at least 3500 (52.5% deuterium incorporation), at least 4000 (60% deuterium incorporation), at least 4500 (67.5% deuterium incorporation), at least 5000 (75% deuterium incorporation), at least 5500 (82.5% deuterium incorporation), at least 6000 (90% deuterium incorporation), at least 6333 (95% deuterium incorporation), at least 6466.7 (97% deuterium incorporation), at least 6600 (99% deuterium incorporation), or at least 6633.3 (99.5% deuterium incorporation).
  • the positions not designated specifically as “D,” “d,” or “deuterium” in semaglutide or pharmaceutically acceptable salts, esters or prodrugs thereof, as provided herein, shall be understood to have hydrogen at its natural abundance isotopic composition.
  • Methods of Treatment [00357] In another aspect, provided herein is a method of treating a disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the compound as provided herein, the composition as provided herein, or the pharmaceutical composition as provided herein, wherein the administering is effective to treat the disease or disorder in the subject. [00358] In some embodiments, the compound or the pharmaceutical composition is administered to the subject using the drug delivery device as provided herein.
  • the disease or disorder is a metabolic disease or disorder, a cardiovascular disease or disorder, chronic kidney disease, or a neurological disease or disorder.
  • the disease or disorder is selected from the group consisting of diabetes, type 1 diabetes, type 2 diabetes, obesity, overweight, metabolic dysfunction–associated WSGR Docket No.: 56017-729.601 fatty liver disease (MAFLD), metabolic dysfunction-associated steatohepatitis (MASH), and nonalcoholic steatohepatitis (NASH).
  • MAFLD fatty liver disease
  • MASH metabolic dysfunction-associated steatohepatitis
  • NASH nonalcoholic steatohepatitis
  • the disease or disorder is selected from the group consisting of arrhythmia, coronary artery disease, heart failure, valve disease, aortic disease, congenital heart disease, heart attack, angina, cardiomyopathy, peripheral arterial disease, atherosclerosis, cardiac dysrhythmias, pericarditis, pulmonary hypertension, stroke, cerebrovascular disease, rheumatic heart disease, atrial fibrillation, Brugada syndrome, aortic stenosis, bradycardia, endocarditis, high cholesterol, and long QT syndrome.
  • the disease or disorder is Parkinson’s disease or Alzheimer disease.
  • the disease or disorder is a neurological disease or disorder.
  • the neurological disease or disorder is selected from the group consisting of epilepsy, Alzheimer disease, dementias, stroke, multiple sclerosis, Parkinson's disease, neuroinfections, brain tumors, amyotrophic lateral sclerosis (ALS), tauopathies, and age-related macular degeneration.
  • the subject is human.
  • the compound or the pharmaceutical composition is administered to the subject via parenteral administration, oral administration, or implantable administration.
  • the compound or the pharmaceutical composition is administered to the subject via subcutaneous administration or intravenous administration.
  • a method of reducing weight in a subject in need thereof comprising administering to the subject a therapeutically effective amount of the compound as provided herein, the composition as provided herein, or the pharmaceutical composition as provided herein, wherein the administering is effective to reduce weight in the subject.
  • the compound or the pharmaceutical composition is administered to the subject using the drug delivery device as provided herein.
  • the subject is human.
  • the subject has obesity or is overweighted.
  • the compound or the pharmaceutical composition is administered to the subject via parenteral administration, oral administration, or implantable administration.
  • the compound or the pharmaceutical composition is administered to the subject via subcutaneous administration or intravenous administration.
  • a method for treating a disease or condition in a subject comprising administering to a subject in need thereof a pharmaceutical composition WSGR Docket No.: 56017-729.601 of the present invention comprising a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof and a pharmaceutically acceptable salt thereof, wherein the composition has a molar ratio of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof to pharmaceutically acceptable salt of from 1:1 to 10:1 or from about 2:1 to about 7:1.
  • the disease or condition is diabetes, particularly type-2 diabetes, a pre-diabetic condition, weight loss, obesity, metabolic dysfunction–associated fatty liver disease (MAFLD) or metabolic dysfunction-associated steatohepatitis (MASH).
  • Pharmaceutical Compositions [00374] In another aspect, provided herein is a pharmaceutical composition comprising one or more salt forms of GLP-l receptor agonist (e.g., semaglutide) as provided herein. [00375] in another aspect, provided herein is a pharmaceutical composition comprising one or more salt forms of GLP-l receptor agonist (e.g., semaglutide) as provided herein, and a pharmaceutically acceptable excipient.
  • the pharmaceutical composition is formulated for parenteral administration, oral administration, or implantable administration. In some embodiments, the pharmaceutical composition is formulated for subcutaneous administration or intravenous administration. In some embodiments, the pharmaceutical composition is formulated for delivery via an implantable drug delivery device, such as an implantable osmotic drug delivery device.
  • an implantable drug delivery device such as an implantable osmotic drug delivery device.
  • a drug delivery device comprising one or more salt forms of GLP-l receptor agonist (e.g., semaglutide) as provided herein, or a pharmaceutical composition as provided herein.
  • the drug delivery device is a syringe, a single-dose pen with an injection needle, or an autoinjector with an injection needle.
  • the drug delivery device is an implantable drug delivery device, such as an implantable osmotic drug delivery device.
  • a drug delivery device comprising a pharmaceutical composition of the present invention comprising a pharmaceutically acceptable salt form GLP-l receptor agonist (e.g., semaglutide), wherein the composition has a molar ratio of a GLP-l receptor agonist (e.g., semaglutide) to pharmaceutically acceptable salt of from 1:1 to 10:1 or from about 2:1 to about 7:1.
  • the drug delivery device is a syringe, single-dose (e.g., autoinjector) pen with an injection needle.
  • the drug delivery device is an implantable drug delivery device, such as an implantable osmotic drug delivery device.
  • implantable osmotic delivery device typically refer to a device used for delivery of a drug (e.g., a nauseogenic compound) to a subject, wherein the device comprises, for example, a reservoir WSGR Docket No.: 56017-729.601 (made, e.g., from a titanium alloy) having a lumen that contains a suspension formulation comprising a drug (e.g., a nauseogenic compound) and an osmotic agent formulation.
  • a drug e.g., a nauseogenic compound
  • a piston assembly positioned in the lumen isolates the suspension formulation from the osmotic agent formulation.
  • a semi-permeable membrane is positioned at a first distal end of the reservoir adjacent the osmotic agent formulation and a diffusion moderator (which defines a delivery orifice through which the suspension formulation exits the device) is positioned at a second distal end of the reservoir adjacent the suspension formulation.
  • the osmotic delivery device is implanted within the subject, for example, subdermally or subcutaneously (e.g., in the inside, outside, or back of the upper arm and in the abdominal area).
  • An exemplary osmotic delivery device includes, but is not limited to, the DUROS® (ALZA Corporation, Mountain View, Calif.) delivery device.
  • DUROS® ALZA Corporation, Mountain View, Calif.
  • examples of terms synonymous to “osmotic delivery device” include, but are not limited to, “osmotic drug delivery device”, “osmotic drug delivery system”, “osmotic device”, “osmotic delivery device”, “osmotic delivery system”, “osmotic pump”, “implantable drug delivery device”, “drug delivery system”, “drug delivery device”, “implantable osmotic pump”, “implantable drug delivery system”, and “implantable delivery system”.
  • Other terms for “osmotic delivery device” are known in the art.
  • continuous delivery typically refers to a substantially continuous release of drug from an osmotic delivery device and into tissues near the implantation site, e.g., subdermal and subcutaneous tissues.
  • an osmotic delivery device releases drug essentially at a predetermined rate based on the principle of osmosis.
  • Extracellular fluid enters the osmotic delivery device through the semi-permeable membrane directly into the osmotic engine that expands to drive the piston at a slow and consistent rate of travel. Movement of the piston forces the drug formulation to be released through the orifice of the diffusion moderator.
  • release of the drug from the osmotic delivery device is at a slow, controlled, consistent rate.
  • substantially steady-state delivery typically refers to delivery of a drug at or near a target concentration over a defined period of time, wherein the amount of the drug being delivered from an osmotic delivery device is substantially zero-order delivery.
  • Substantial zero-order delivery of an active agent e.g., a disclosed salt of semaglutide
  • the rate of drug delivered is constant and is independent of the drug available in the delivery system; for example, for zero-order delivery, if the rate of drug delivered is graphed against time and a line is fitted to the data the line has a slope of approximately zero, as determined by standard methods (e.g., linear regression).
  • compositions described herein comprise one or more salt forms of GLP- l receptor agonist (e.g., semaglutide) as described herein in combination with one or more WSGR Docket No.: 56017-729.601 pharmaceutically or acceptable carriers, diluents or excipients.
  • Such pharmaceutical compositions can further comprise buffers such as neutral buffered saline, phosphate buffered saline and the like; carbohydrates such as glucose, mannose, sucrose or dextrans, mannitol; proteins; polypeptides or amino acids such as glycine; antioxidants; chelating agents such as EDTA or glutathione; adjuvants (e.g., aluminum hydroxide); and preservatives.
  • a pharmaceutical composition used in the therapeutic methods of the invention is formulated to be compatible with its intended route of administration.
  • the pharmaceutical compositions can be formulated in liquid or solid dosage forms and as instant or controlled/sustained release formulations. Suitable dosage forms for oral ingestion by a subject include powders, tablets, pills, granules, dragees, hard and soft shell capsules, liquids, gels, syrups, slurries, suspensions, emulsions and the like.
  • Oral compositions generally include an inert diluent or an edible carrier. They can be enclosed in gelatin capsules or compressed into tablets.
  • preparation is intended to include the formulation of the compositions with encapsulating material as a carrier providing a capsule in which the active compositions with or without other carriers, is surrounded by a carrier, which is thus in association with it.
  • Pharmaceutically compatible binding agents, and/or adjuvant materials can be included as part of the composition.
  • the tablets, granules, pills, capsules, troches and the like can contain any of the following ingredients, or compounds of a similar nature: a binder such as microcrystalline cellulose, gum tragacanth or gelatin; an excipient such as starch or lactose; dissolution retardant; antiadherants; cationic exchange resin; wetting agents; antioxidants; preservatives; a disintegrating agent such as alginic acid, Primogel, or corn starch; a lubricant such as magnesium stearate or Sterotes; a glidant such as colloidal silicon dioxide; a preservative; a colorant; a sweetening agent such as sugars such as dextrose, sucrose or saccharin; or a flavoring agent such as peppermint, methyl salicylate, or orange flavoring, each of these being synthetic and/or natural.
  • a binder such as microcrystalline cellulose, gum tragacanth or gelatin
  • an excipient such as starch or lac
  • the pharmaceutical compositions are prepared with carriers that will protect the components of the composition against rapid elimination from the body, such as a controlled release formulation, including implants and microencapsulated delivery systems.
  • a controlled release formulation including implants and microencapsulated delivery systems.
  • Biodegradable, biocompatible polymers can be used, such as ethylene vinyl acetate, polyanhydrides, polyglycolic acid, collagen, polyorthoesters, and polylactic acid. Methods for preparation of such formulations will be apparent to those skilled in the art. The materials can also be obtained commercially.
  • Liposomal suspensions can also be used as pharmaceutically acceptable carriers. These can be prepared according to methods known to those skilled in the art, for example, as described in U.S. Pat. No.4,522,811.
  • the pharmaceutical compositions are delivered in the WSGR Docket No.: 56017-729.601 form of an aerosol spray from pressured container or dispenser which contains a suitable propellant, e.g., a gas such as carbon dioxide, or a nebulizer.
  • a suitable propellant e.g., a gas such as carbon dioxide, or a nebulizer.
  • Systemic administration can also be by transmucosal or transdermal means.
  • penetrants appropriate to the barrier to be permeated are used in the formulation. Such penetrants are generally known in the art, and include, for example, for transmucosal administration, detergents, bile salts, and fusidic acid derivatives.
  • Transmucosal administration can be accomplished through the use of nasal sprays or suppositories.
  • the active agents are formulated into ointments, salves, gels, or creams, emulsion, a solution, a suspension, or a foam, as generally known in the art.
  • the penetration of the drug into the skin and underlying tissues can be regulated, for example, using penetration enhancers; the appropriate choice and combination of lipophilic, hydrophilic, and amphiphilic excipients, including water, organic solvents, waxes, oils, synthetic and natural polymers, surfactants, emulsifiers; by pH adjustments; use of complexing agents and other techniques, such as iontophoresis, may be used to regulate skin penetration of the active ingredient.
  • the compositions may also be formulated in rectal compositions, such as suppositories (e.g., with conventional suppository bases such as cocoa butter and other glycerides) or retention enemas.
  • compositions suitable for injectable use include one or more salt forms of GLP-l receptor agonist (e.g., semaglutide) as described herein in sterile aqueous solutions (where water soluble) or dispersions and sterile powders for the extemporaneous preparation of sterile injectable solutions or dispersion.
  • GLP-l receptor agonist e.g., semaglutide
  • Solutions or suspensions used for parenteral, intradermal, or subcutaneous application can include the following components: a sterile diluent such as water for injection, saline solution, fixed oils, polyethylene glycols, glycerin, propylene glycol or other synthetic solvents; antibacterial agents such as benzyl alcohol or methyl parabens; antioxidants such as ascorbic acid or sodium bisulfite; chelating agents such as ethylenediaminetetraacetic acid; buffers such as acetates, citrates or phosphates and agents for the adjustment of tonicity such as sodium chloride or dextrose.
  • the vehicle may contain water, synthetic or vegetable oil, and/or organic cosolvents.
  • parenteral formulation would be reconstituted or diluted prior to administration. pH can be adjusted with acids or bases, such as hydrochloric acid or sodium hydroxide. Depot formulations, providing controlled or sustained release of an invention composition, may include injectable suspensions of nano/micro particles or nano/micro or nonmicronized crystals.
  • suitable carriers include physiological saline, bacteriostatic water, Cremophor ELTM (BASF, Parsippany, N.J.) or phosphate buffered saline (PBS).
  • the carrier can be a solvent or dispersion medium containing, for example, water, ethanol, poly(ol) (for example, glycerol, propylene glycol, and liquid polyetheylene glycol, and the like), and suitable mixtures thereof.
  • the proper fluidity can be maintained, for example, by the use of a coating such as lecithin, by the maintenance of the required particle size in the case of dispersion and by the use of surfactants.
  • Sterile injectable solutions can be prepared by incorporating the composition in the required amount in an appropriate solvent with one or a combination of ingredients enumerated above, as required, followed by filtered sterilization. Prevention of the action of microorganisms can be achieved by various antibacterial and antifungal agents, for example, parabens, chlorobutanol, phenol, ascorbic acid, thimerosal, and the like.
  • dispersions are prepared by incorporating the active composition into a sterile vehicle which contains a basic dispersion medium and the required other ingredients from those enumerated above.
  • the preferred methods of preparation are vacuum drying and freeze-drying which yields a powder of the active ingredient plus any additional desired ingredient from a previously sterile-filtered solution thereof.
  • isotonic agents for example, sugars, polyalcohols such as manitol, sorbitol, and sodium chloride in the composition.
  • Prolonged absorption of the injectable compositions can be brought about by including in the composition an agent which delays absorption, for example, aluminum monostearate and gelatin.
  • the parenteral preparation can be enclosed in ampoules, disposable syringes or multiple dose vials made of glass or plastic.
  • Examples of pharmaceutically or physiologically acceptable carriers, diluents or excipients include, but are not limited to, antifoaming agents, antioxidants, binders, carriers or carrier materials, dispersing agents, viscosity modulating agents, diluents, filling agents, lubricants, glidants, plasticizers, solubilizers, stabilizers, suspending agents, surfactants, viscosity enhancing agents, and wetting agents.
  • a “carrier” or “carrier materials” include any commonly used excipients in pharmaceutics and should be selected on the basis of compatibility with compositions disclosed herein and the release profile properties of the desired dosage form.
  • Exemplary carrier materials include, e.g., binders, suspending agents, disintegration agents, filling agents, surfactants, solubilizers, stabilizers, lubricants, wetting agents, diluents, and the like.
  • a “pharmaceutically acceptable carrier,” as used herein, is intended to include any and all solvents, including water, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying WSGR Docket No.: 56017-729.601 agents, antiinflammatory, stabilizers, and the like, compatible with pharmaceutical administration. The use of such media and agents for pharmaceutically active substances is well known in the art.
  • compositions may additionally contain liquids such as water, saline, glycerol, ethanol or auxiliary substances such as wetting or emulsifying agents, pH buffering substances and the like. Carriers may enable the pharmaceutical compositions to be formulated into tablets, pills, dragees, capsules, liquids, gels, syrups, slurries, suspensions to aid intake by the patient.
  • “Pharmaceutically compatible carrier materials” can include, but are not limited to, acacia, gelatin, colloidal silicon dioxide, calcium glycerophosphate, calcium lactate, maltodextrin, glycerine, magnesium silicate, polyvinylpyrrollidone (PVP), cholesterol, cholesterol esters, sodium caseinate, soy lecithin, taurocholic acid, phosphotidylcholine, sodium chloride, tricalcium phosphate, dipotassium phosphate, cellulose and cellulose conjugates, sugars sodium stearoyl lactylate, carrageenan, monoglyceride, diglyceride, pregelatinized starch, and the like.
  • PVP polyvinylpyrrollidone
  • Diluents can also be used to stabilize compounds because they can provide a more stable environment. Salts dissolved in buffered solutions (which also can provide pH control or maintenance) are utilized as diluents in the art, including, but not limited to a phosphate buffered saline solution. In certain embodiments, diluents increase bulk of the composition to facilitate compression or create sufficient bulk for homogenous blend for capsule filling.
  • Such compounds include e.g., lactose, starch, mannitol, sorbitol, dextrose, microcrystalline cellulose such as Avicel®; dibasic calcium phosphate, dicalcium phosphate dihydrate; tricalcium phosphate, calcium phosphate; anhydrous lactose, spraydried lactose; pregelatinized starch, compressible sugar, such as DiPac® (Amstar); mannitol, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose acetate stearate, sucrose-based diluents, confectioner’s sugar; WSGR Docket No.: 56017-729.601 monobasic calcium sulfate monohydrate, calcium sulfate dihydrate; calcium lactate trihydrate, dextrates; hydrolyzed cereal solids, amylose; powdered cellulose, calcium carbonate; glycine, kaolin; mannitol, sodium chloride; inositol,
  • compositions of the invention may be preblended or each component may be added separately to the same environment according to a predetermined dosage for the purpose of achieving the desired concentration level of the treatment components and so long as the components eventually come into intimate admixture with each other.
  • the invention may be administered or delivered on a continuous or intermittent basis.
  • a pharmaceutical composition comprising a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof and a pharmaceutically acceptable salt thereof, wherein the composition has a molar ratio of pharmaceutically acceptable cation or anion: a ionic form of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof of from 2:1 to 10:1.
  • the pharmaceutically acceptable cation comprises a cation selected from the group consisting of aluminum, sodium, lithium, potassium, magnesium, magnesium, zinc, NH4 + , NMe4 + and N(C1–4alkyl)4 + .
  • the pharmaceutical composition is formulated as a sterile solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 0.50 ml to 2.5 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 0.50 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 0.75 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 1.0 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 1.25 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 1.50 ml solution.
  • the pharmaceutical composition is formulated as a sterile 1.75 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 2.0 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 2.25 ml solution. In some embodiments, the pharmaceutical composition is formulated as a sterile 2.5 ml solution. [00398] In some embodiments, the pharmaceutical composition comprises 0.10 mg to 20.0 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the pharmaceutical composition comprises 0.10 mg, 0.25 mg, 0.50 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.34 mg, 1.5 mg, 1.7 mg, 1.75 mg, 2.0 mg, 2.25 mg, 2.4 mg, 2.5 mg, 2.75 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 7.0 mg, 8.0 mg, 9.0 mg, 10.0 mg, 11.0 mg, 12.0 mg, 13.0 mg, 14.0 mg, 15.0 mg, 16.0 mg, 17.0 mg, 18.0 mg, 19.0 mg or 20.0 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • a GLP-l receptor agonist e.g., semaglutide
  • the pharmaceutical composition comprises a 1.0 mL sterile solution and 1.34 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof. In some embodiments, the pharmaceutical composition comprises a 1.5 mL sterile solution and 2.0 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the pharmaceutical composition comprises a sterile solution of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, further comprising inactive ingredients selected from the group consisting of disodium phosphate dihydrate, propylene glycol, phenol, and water for injections.
  • the pharmaceutical composition comprises a sterile solution of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, wherein each 1.0 ml of the solution further comprising inactive ingredients selected from the group consisting of 1.42 mg of disodium phosphate dihydrate, 14.0 mg of propylene glycol, 5.50 mg of phenol and water for injections.
  • the pharmaceutical composition comprises a sterile solution of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof at pH 7.4.
  • the pharmaceutical composition comprises a 0.50 mL sterile solution and 0.25 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the pharmaceutical composition comprises a 0.50 mL sterile solution and 0.50 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the pharmaceutical composition comprises a 0.50 mL sterile solution and 1.0 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof. In some embodiments, the pharmaceutical composition comprises a 0.75 mL sterile solution and 1.7 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof. In some embodiments, the pharmaceutical composition comprises a 0.75 mL sterile solution and 2.4 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the pharmaceutical composition comprises a sterile solution of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, further comprising inactive ingredients selected from the group consisting of disodium phosphate dihydrate, sodium chloride, and water for injections.
  • the pharmaceutical composition comprises a sterile solution of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, wherein each 1.0 ml of the solution further comprising inactive ingredients selected from the group consisting of 1.42 mg of disodium phosphate dihydrate, 8.25 mg of sodium chloride, and water for injections.
  • the pharmaceutical composition comprises a sterile solution of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof at pH 7.4.
  • a GLP-l receptor agonist e.g., semaglutide
  • the pharmaceutical composition is formulated as a tablet comprising 3.0 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the pharmaceutical composition is formulated as a tablet comprising 7.0 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the pharmaceutical composition is formulated as a tablet comprising 14.0 mg a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof.
  • the pharmaceutical composition is formulated as a tablet comprising a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof, further comprising inactive ingredients selected from the group consisting of magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC).
  • the pharmaceutical composition as provided herein further comprises at least one permeation enhancer.
  • the at least one permeation enhancer is selected from the group consisting of salcaprozate sodium (SNAC), sodium caprylate, sodium caprate, a bile salt, ethylenediaminetetraacetic acid (EDTA), ethylene glycolbis-(2-aminoethylether)-N,N,N',N'- tetraacetic acid (EGTA), and 3-[N,N-Dimethyl(3-palmitoylaminopropyl)-ammonio]- propanesulfonate (PPS), and any combination thereof.
  • SNAC salcaprozate sodium
  • EDTA ethylenediaminetetraacetic acid
  • EGTA ethylene glycolbis-(2-aminoethylether)-N,N,N',N'- tetraacetic acid
  • PPS 3-[N,N-Dimethyl(3-palmitoylaminopropyl)-ammonio]- propanesulfonate
  • kits comprising the compound as provided herein, the composition as provided herein, the pharmaceutical composition as provided herein, or the drug delivery device as provided herein. In some embodiments, the kit as provided herein further comprises an instruction for use. [00406] Also disclosed herein, in certain embodiments, are kits and articles of manufacture for use with one or more methods described herein.
  • kits include a carrier, package, or container that is compartmentalized to receive one or more containers such as vials, tubes, and the like, each of the container(s) comprising one of the separate elements to be used in a method described herein.
  • Suitable containers include, for example, bottles, vials, syringes, and test tubes.
  • the containers are formed from a variety of materials such as glass or plastic.
  • the articles of manufacture provided herein contain packaging materials. Examples of pharmaceutical packaging materials include, but are not limited to, blister packs, bottles, tubes, bags, containers, bottles, and any packaging material suitable for a selected formulation and intended mode of administration and treatment.
  • the container(s) include the composition of the invention, and optionally in addition with therapeutic regimens or agents disclosed herein.
  • kits optionally include an WSGR Docket No.: 56017-729.601 identifying description or label or instructions relating to its use in the methods described herein.
  • a kit typically includes labels listing contents and/or instructions for use, and package inserts with instructions for use. A set of instructions will also typically be included.
  • a label is on or associated with the container.
  • a label is on a container when letters, numbers or other characters forming the label are attached, molded or etched into the container itself; a label is associated with a container when it is present within a receptacle or carrier that also holds the container, e.g., as a package insert.
  • a label is used to indicate that the contents are to be used for a specific therapeutic application. The label also indicates directions for use of the contents, such as in the methods described herein.
  • kits comprising a pharmaceutical composition of the present invention, the composition comprising a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof and a pharmaceutically acceptable salt thereof, wherein the composition has a molar ratio of a GLP-l receptor agonist (e.g., semaglutide) or a functional variant thereof to pharmaceutically acceptable salt of from 1:1 to 10:1 or from about 2:1 to about 7:1.
  • the kit further comprises instructions for use.
  • the disclosure is further illustrated by the following examples which should not be construed as limiting. The examples are illustrative only, and are not intended to limit, in any manner, any of the aspects described herein.
  • Table 1 Exemplary Sequences WSGR Docket No.: 56017-729.601 Table 2. Sequence and Chemical Structure of Semaglutide [00413]
  • a compound comprising the structure of Formula I: Formula I, wherein: is an anion of semaglutide; and is a cationic component.
  • R 8 , R 9 , and R 10 are independently C1-C5 alkyl, and R 11 is C2-C5 alkyl that is unsubstituted or substituted with 1 or more hydroxyl.
  • the cationic component is selected from the group of cationic components listed in Table 3.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a molar ratio of anion of semaglutide to cationic component that is selected from the group consisting of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7 or any ratio between any two of these values.
  • the cationic component is selected from the group of cationic components listed in Table 3, further provided in a weight % (wt. %) of the cationic component, as listed in Table 3, relative to 100 wt. % of the anion of semaglutide.
  • the cationic component is not choline.
  • the cationic is not choline having a wt % of cationic component relative to (100 wt %) peptide of about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6 or 1:7 or any ratio between any two of these values.
  • a compound comprising the structure of Formula IIa, Formula IIb, Formula IIc, or any combination thereof: Formula IIa, any combination thereof is one or more cations of semaglutide; and is an anionic component.
  • the anionic component is selected from the group of anionic components listed in Table 4.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a molar ratio of one or more cations of semaglutide to anionic component that is about 1:1, 1:2, 1:3, or 1:4.
  • the anionic component is selected from the group of anionic components listed in Table 4, further provided in a weight % (wt.
  • Salts are formed when a compound that is ionized in solution forms a strong ionic interaction with an oppositely charged counterion, leading to crystallization of the salt form.
  • the drug and counterion are ionized according to the dielectric constant of the liquid medium.
  • the charged groups in the drug's structure and the counterion are attracted by an intermolecular coulombic force. During favorable conditions, this force crystallizes the salt form.
  • All acidic and basic compounds can participate in salt formation. However, the success and stability of salt formation depends upon the relative strength of the acid or base or the acidity or basicity constants of the species involved.
  • Salt forms of drugs have a large effect on the drugs' quality, safety, and performance.
  • the properties of salt-forming species i.e., counterions) significantly affect the pharmaceutical properties of a drug and can greatly benefit chemists and formulators in various facets of drug discovery and development.
  • the main objective of a salt-selection study is to identify the salt form most suitable for development.
  • Relative pKa of the drug and counterion are often considered for successful salt formation as well.
  • the pKa of the counterion is often lower than the pKa of the drug.
  • the pKa of the counterion is often higher than the pKa of the drug.
  • Salts can be prepared on a small scale using various well known methods. Forming salts from free acid or base is the most common method. The free acid or base of the drug substance is combined with the counterion base or acid in specific molar ratios in a suitable solvent system. The salt form is then isolated, and the solid precipitate is recrystallized.
  • An alternative method is to form salts through salt exchange.
  • a counterion salt is treated with a free acid or base in a specific molar concentration in a suitable solvent.
  • the solid is then isolated and recrystallized.
  • GLP-l R Agonist Semaglutide [00425]
  • FDA Food and Drug Administration
  • Ozempic ⁇ injection and Rybelsus ⁇ tablet are approved to lower blood sugar levels in adults with type 2 diabetes mellitus, in addition to diet and exercise.
  • Ozempic ⁇ injection is also approved to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes mellitus and known heart disease.
  • Wegovy ⁇ injection is approved to help WSGR Docket No.: 56017-729.601 adults and children aged 12 years and older with obesity or some adults with excess weight (overweight), who also have weight-related medical problems, to lose weight and keep the weight off, in addition to diet and exercise.
  • semaglutide comprises seven ionizable carboxylate groups as shown in FIG. 1, each of Ozempic ⁇ , Wegovy ⁇ , and Rybelsus ⁇ comprises the free-acid form of semaglutide with respect to all ionizable carboxylate groups of this peptide.
  • Ozempic ⁇ is a sterile, aqueous, clear and colorless solution.
  • Each pre-filled pen contains Ozempic ⁇ solution containing 0.25, 0.50, 1.0 or 2.0 mg of the free-acid form of semaglutide, and each 1 mL of Ozempic ⁇ solution contains 1.34 mg of the free-acid form of semaglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14.0 mg; phenol, 5.50 mg; and water for injections.
  • Ozempic ⁇ has a pH of approximately 7.4.
  • Wegovy ⁇ is a sterile, aqueous, clear and colorless solution.
  • Each 0.5 mL single-dose pen contains a solution of Wegovy ⁇ containing 0.25 mg, 0.5 mg or 1 mg of the free-acid form of semaglutide, and each 0.75 mL single-dose pen contains a solution of Wegovy ⁇ containing 1.7 or 2.4 mg of the free-acid form of semaglutide.
  • Each 1 mL of Wegovy ⁇ solution contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; sodium chloride, 8.25 mg; and water for injection.
  • Wegovy ⁇ has a pH of approximately 7.4.
  • each tablet of Rybelsus ⁇ contains 3 mg, 7 mg or 14 mg of the free-acid form of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC also known as salcaprozate sodium).
  • SNAC sodium N-[8-(2-hydroxybenzoyl) amino] caprylate
  • % ratios of a WSGR Docket No.: 56017-729.601 counterion to semaglutide generally, ranging from 0.1 wt. % to 50.0 wt. % counterion relative to 99.9 wt. % to 50.0 wt. % semaglutide, or in the molar ratios of a counterion, ester and/or prodrug to semaglutide, generally ranging from 1:1 to 100:1, provide surprising and superior results, including enhanced stability and improved solubility in an aqueous environment relative to the free acid form of semaglutide.
  • an exemplary embodiment of the GLP-l receptor agonist or a functional variant thereof e.g., semaglutide
  • the new compounds as provided herein may allow lower dosing (and reduced cost of goods, i.e., COGs) as an additional means to achieve greater efficacy than the existing formulations of the free acid form of semaglutide).
  • Cationic salts of semaglutide in molar ratios of from about 1:1 to about 1:7 peptide:cation are prepared using from about 1 to 7 molar equivalents of any given “cation” bicarbonate in water and driving off carbon dioxide to compel salt formation.
  • semaglutide:choline and semaglutide:sodium are each prepared having a 1:4 molar ratio of peptide:cation.
  • cationic salts of semaglutide having alternative cations can be prepared in molar ratios of from about 1:1 to about 1:7 peptide:cation using the same or substantially same general procedure.
  • FIG. 5 shows 1H proton nuclear magnetic resonance (NMR) spectra of choline (at baseline, fourth spectrum from top), semaglutide free acid (third spectrum from top), choline- semaglutide having a molar ratio of semaglutide:choline of 1:4 (second spectrum from top). and sodium-semaglutide having a molar ratio of semaglutide:sodium of 1:4 (top spectrum).
  • NMR nuclear magnetic resonance
  • Anionic salts of semaglutide in molar ratios of from about 1:1 to about 1:4 peptide:anion are prepared using from about 1 to 4 molar equivalents of any given “anionic” acid in water to drive salt formation.
  • semaglutide:chloride and semaglutide:acetate are each prepared having a 1:4 molar ratio of peptide:anion.
  • anionic salts of semaglutide having alternative anions for example, toluenesulfonate, bromide, etc.
  • Esters of semaglutide in molar ratios of from about 1:1 to about 1:7 peptide:ester are prepared using from about 1 to 7 molar equivalents of any given alcohol in tetrahydrofuran (THF), dimethylsulfoxide (DMSO) or dimethylformamide (DMF).
  • THF tetrahydrofuran
  • DMSO dimethylsulfoxide
  • DMF dimethylformamide
  • the ethyl ester of semaglutide is prepared having a 1:1 molar ratio of peptide:ethyl ester.
  • esters of semaglutide having alternative ester groups can be prepared in molar ratios of about 1:1 to about 1:7 peptide:ester using the same or substantially same general procedure.
  • WSGR Docket No.: 56017-729.601 Preparation of ethyl ester of semaglutide having a 1:1 molar ratio. In a 100-mL round bottom flask, 10 mL THF is combined with semaglutide (100 mg; 24.3 mmol; 1 equivalent) and the mixture is cooled to 0 ⁇ C with stirring.
  • Ion Exchange Preparations of Salt Forms of Semaglutide [00438] Ion Exchange Chromatography of Semaglutide. Semaglutide of high purity (e.g., greater than 90%) can be subjected to salt exchange according to numerous published methods, including those described in US Patent Application Publication No.20210206800A1, which is incorporated by reference in its entirety. [00439] For example, fractions containing semaglutide of >90% purity are loaded onto RP-HPLC column packed with C8, 10 ⁇ m silica having a diameter and length of 10 mm ⁇ 250 mm with a flow rate of 4.7 mL/min. The loading amount is about 1.0 g.
  • Solubility profiles are assessed by mixing 50 ⁇ L aliquots of a 500 ⁇ M aqueous solution of each compound or its salt with 50 ⁇ L of 100 mM pH-adjusted buffer solutions (lactate pH 3–5; bis-tris-propane pH 6–8) to a nominal concentration of 250 ⁇ M. Samples are left overnight at room temperature to reach solubility equilibrium and subsequently centrifuged to isolate supernatant.
  • the peptide concentration in the supernatant is determined by UPLC using an ACQUITY UPLC column (bridged ethylsiloxane/silica hybrid C181.7 ⁇ m–2.1 ⁇ 50 mm) with a flow rate of 0.45 mL/min at 40 °C and detection at 214 nm.
  • a gradient combining eluent A (0.05% TFA in water) and eluent B (0.05% TFA in acetonitrile) is applied (%A/%B: 0 min: 95/5; 0–1/2 min: linear to 90/10; 1/2–21/2 min: linear to 35/65; 21/2–3 min: linear 0/100; 3– 4 min: 0/100; 4–41/2 min: linear to 95/5; and 5 min: 95/5).
  • Measured values at or above 200 ⁇ M WSGR Docket No.: 56017-729.601 are reported as “>200 ⁇ M,” whereas measured values below 200 ⁇ M were reported according to their measured value.
  • Aggregation of peptides is one of the most common degradation pathways observed in almost all phases of drug product development. Aggregation can take several different forms, and the term is often used to describe a variety of processes during which peptide molecules assemble into larger species. Aggregates can be amorphous or structured such as amyloid fibrils. In severe cases, it leads to a loss in activity and/or induces toxicity and immunogenicity. Many examples of aggregation are initiated by a loss of secondary structure (unfolding). For example, semaglutide free acid forms fibrils consisting of ⁇ -sheets with aging or with small changes in the manufacturing process.
  • Semaglutide free acid is also susceptible to an unusual physical instability in the presence of hydrophobic surfaces, i.e., spontaneous emulsification, also known as “ouzo formation.”
  • spontaneous emulsification also known as “ouzo formation.”
  • Measurements of the propensity for semaglutide free acid and its various exemplary salt forms to aggregate or emulsify can be undertaken according to numerous published methods, such as those described in Li, Q et al., Surface-mediated spontaneous emulsification of the acylated peptide, semaglutide, Natl Acad Sci U S A, 2024 Jan 30;121(5); Epub 2024 Jan 16.
  • Li, Q et al. describes light scattering, small-angle X-ray scattering, and circular dichroism measurements that are used to characterize the physical properties of the semaglutide colloidal phase, including size distribution, shape, secondary structure, internal structure, and internal composition of this peptide, as a function of solution physico-chemical conditions.
  • Example 8 Li, Q et al. describes light scattering, small-angle X-ray scattering, and circular dichroism measurements that are used to characterize the physical properties of the semaglutide colloidal phase, including size distribution, shape, secondary structure, internal structure, and internal composition of this peptide, as a function of solution physico-chemical conditions.
  • Example 8 describes light scattering, small-angle X-ray scattering, and circular dichroism measurements that are used to characterize the physical properties of the semaglutide colloidal phase, including size distribution, shape, secondary structure, internal structure, and internal composition of this peptide, as a function of solution physico-chemical conditions.
  • Solubility Studies of Semaglutide Salts at Ambient Temperature [00444] Solubility of various exemplary salts of semaglutide and the semaglutide base form was assessed by mixing the lyophilized peptide of an exemplary salt of semaglutide, i.e., the choline- semaglutide salt, and the semaglutide base form with water at room temperature at the peptide concentrations of 1, 5 and 10 mg/mL. The mixed samples were monitored for appearance of clear solutions (C) or visible precipitation (P). Examples of clear solutions (C) and solutions that exhibited precipitation (P) are shown in FIG. 2A (clear) and FIG. 2B (precipitation). FIG.
  • FIG. 2A shows a photograph of a representative clear solution (C) of various forms of semaglutide in water or dimethyl sulfoxide (DMSO)
  • FIG.2B shows a photograph of a representative solution of various forms of semaglutide having visible precipitation (P) in water or dimethyl sulfoxide WSGR Docket No.: 56017-729.601 (DMSO).
  • Table 5 presents the data obtained from these studies. Table 5.
  • Example 9 Solubility Studies of Various Exemplary Salts of Semaglutide at High and Low Temperature for Extended Periods.
  • Samples were prepared to contain the lyophilized peptide of various exemplary salts of semaglutide at the concentration of 5 mg/mL, with the exception of the semaglutide base form (i.e., free acid), which was insoluble even at 1 mg/mL, in either dimethyl sulfoxide (DMSO) or water.
  • DMSO dimethyl sulfoxide
  • the samples were stored at three different temperatures (37 ⁇ C, 21 ⁇ C, 4 ⁇ C).
  • the samples were analyzed by reversed phase high-performance liquid chromatography (RP-HPLC) using Agilent 1260.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Hospice & Palliative Care (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Psychiatry (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Immunology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne des composés comprenant une forme ionique d'un agoniste du récepteur GLP-1, tel que le sémaglutide, et un contre-ion de celui-ci, des esters supplémentaires et des dérivés de promédicament de sémaglutide, ainsi que leurs procédés d'utilisation.
PCT/US2025/017967 2024-02-28 2025-02-28 Compositions contenant des sels pharmaceutiquement acceptables et d'autres dérivés d'agonistes du récepteur du peptide-1 de type glucagon et leurs utilisations Pending WO2025184589A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US202463558839P 2024-02-28 2024-02-28
US63/558,839 2024-02-28
US202463658311P 2024-06-10 2024-06-10
US63/658,311 2024-06-10
US202463710490P 2024-10-22 2024-10-22
US63/710,490 2024-10-22

Publications (1)

Publication Number Publication Date
WO2025184589A1 true WO2025184589A1 (fr) 2025-09-04

Family

ID=96921717

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/017967 Pending WO2025184589A1 (fr) 2024-02-28 2025-02-28 Compositions contenant des sels pharmaceutiquement acceptables et d'autres dérivés d'agonistes du récepteur du peptide-1 de type glucagon et leurs utilisations

Country Status (1)

Country Link
WO (1) WO2025184589A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220409523A1 (en) * 2017-12-07 2022-12-29 Adocia Compositions in the form of an injectable aqueous solution comprising amylin, an amylin receptor agonist or an amylin analog and a co-polyamino acid
WO2023086499A1 (fr) * 2021-11-10 2023-05-19 I2O Therapeutics, Inc. Compositions liquides ioniques
WO2023166179A1 (fr) * 2022-03-03 2023-09-07 Cyprumed Gmbh Formulations pharmaceutiques orales améliorées de peptides et de protéines thérapeutiques
US20240041984A1 (en) * 2015-09-25 2024-02-08 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic formulations in aprotic polar solvents
US20240059753A1 (en) * 2022-07-15 2024-02-22 Pep2Tango Therapeutics Inc. Compositions including multi-agonist peptides and methods of manufacture and use

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240041984A1 (en) * 2015-09-25 2024-02-08 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic formulations in aprotic polar solvents
US20220409523A1 (en) * 2017-12-07 2022-12-29 Adocia Compositions in the form of an injectable aqueous solution comprising amylin, an amylin receptor agonist or an amylin analog and a co-polyamino acid
WO2023086499A1 (fr) * 2021-11-10 2023-05-19 I2O Therapeutics, Inc. Compositions liquides ioniques
WO2023166179A1 (fr) * 2022-03-03 2023-09-07 Cyprumed Gmbh Formulations pharmaceutiques orales améliorées de peptides et de protéines thérapeutiques
US20240059753A1 (en) * 2022-07-15 2024-02-22 Pep2Tango Therapeutics Inc. Compositions including multi-agonist peptides and methods of manufacture and use

Similar Documents

Publication Publication Date Title
EP3517538B1 (fr) Dérivé de pyrazolopyridine ayant un effet agoniste du récepteur glp-1
RU2720677C1 (ru) Соединение, представляющее собой пролекарство ланостерина, а также способ его получения и его применение
AU2012360094B9 (en) FGF receptor (FGFR) agonist dimeric compounds, process for the preparation thereof and therapeutic use thereof
JP6944462B2 (ja) チエノピリミジンジオンａｃｃ阻害剤の固体形態およびその生成のための方法
ES2611040T3 (es) Derivados de insulina
CN117222631A (zh) 苯基-[1,3]二氧杂环戊烯并[4,5-c]吡啶基-苯基-、苯基-[1,3]二氧杂环戊烯并[4,5-c]吡啶基-杂芳基-或苯基-[1,3]二氧杂环戊烯并[4,5-c]吡啶基-哌啶基-甲基-氧杂环丁烷基甲基-1h-苯并[d]咪唑-甲酸衍生物及其使用方法
CN113631535B (zh) 治疗铁死亡相关紊乱的杂芳基和双杂环芳基衍生物
US20240294569A1 (en) Modulators of sortilin activity
AU2022336407A1 (en) Solid forms of 2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2s)-oxetan-2-ylmethyl]-1h-benzimidazole-6-carboxylic acid, 1,3-dihydroxy-2-(hydroxymethyl)propan-2-amine salt
US9156826B2 (en) Asymmetrical reversible neuromuscular blocking agents of ultra-short, short, or intermediate duration
TW201402537A (zh) 犬尿胺酸－３－單氧化酶抑制劑，其醫藥組成物及使用方法
TWI744275B (zh) 2環性雜環化合物
TW202000659A (zh) 六氫吡啶基-3-(芳氧基)丙醯胺及丙酸酯
WO2024063143A1 (fr) Composé à cycle condensé ayant un effet agoniste du récepteur glp-1
US20190169175A1 (en) Novel pyridinium compounds
WO2022133588A1 (fr) Composés inhibiteurs de virus à arn et leurs utilisations
BR112020011479A2 (pt) composições na forma de uma solução aquosa injetável caracterizada pelo fato de que compreende amilina, um agonista do receptor de amilina ou um análogo de amilina e um co-poliaminoácido
KR101682427B1 (ko) 통증 및 기타 질병을 치료하기 위한 화합물 및 방법
WO2025007938A1 (fr) Classe d'inhibiteurs de mort cellulaire programmée, son procédé de préparation et son utilisation
KR20090122218A (ko) ５-(２,４-디히드록시-５-이소프로필-페닐)-４-(４-모르폴린-４-일메틸-페닐)-이속사졸-３-카르복실산 에틸아미드의 산 부가염, 수화물 및 다형체, 및 이들 형태를 포함하는 제제
CN103304573B (zh) 石蒜碱类化合物在制备抗肿瘤药物的应用
WO2025184589A1 (fr) Compositions contenant des sels pharmaceutiquement acceptables et d'autres dérivés d'agonistes du récepteur du peptide-1 de type glucagon et leurs utilisations
WO2025184608A1 (fr) Compositions comprenant des sels pharmaceutiquement acceptables et d'autres dérivés d'un analogue d'amyline, leurs utilisations
KR20230171471A (ko) 글루카곤 유사 펩티드 화합물
KR101969345B1 (ko) 펩타이드가 결합된 안정한 아스코르빈산 유도체를 포함하는 피부 염증 완화용 조성물

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25762758

Country of ref document: EP

Kind code of ref document: A1