Claims for Patent: 11,318,191

Summary for Patent: 11,318,191

Title:	GLP-1 compositions and uses thereof
Abstract:	The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.1% (w/w) phenol and above 6.4 mg/ml sodium chloride, their preparation, kits comprising such compositions as well as uses thereof.
Inventor(s):	Engelund; Dorthe Kot (Holte, DK), Snitker; Soeren (Holte, DK), Louw; Andrew Mark (Vaerloese, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	17/177,438
Patent Claims:	1. A liquid pharmaceutical composition comprising: 0.5 to 10 mg/mL semaglutide, 0.0% (w/w) to 0.1% (w/w) phenol, and 8.2 to 8.9 mg/mL sodium chloride. 2. The liquid pharmaceutical composition according to claim 1 comprising: 0.5 to 3.5 mg/mL semaglutide. 3. The liquid pharmaceutical composition according to claim 1 comprising: 3.2 mg/mL semaglutide. 4. The liquid pharmaceutical composition according to claim 1 further comprising: 0.1 to 50 mM of a buffer. 5. The liquid pharmaceutical composition according to claim 4, wherein the buffer is a phosphate buffer. 6. The liquid pharmaceutical composition according to claim 5, wherein the phosphate buffer is present in a concentration of 1 to 2 mg/mL. 7. The liquid pharmaceutical composition according to claim 1, wherein the pharmaceutical composition has a pH in the range of 6.0 to 10.0. 8. The liquid pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is a parenteral composition. 9. The liquid pharmaceutical composition according to claim 1 further comprising: 0.5 to 3.5 mg/mL semaglutide, 0.01 to 50 mM buffer, and pH in the range of about 7 to about 8. 10. The liquid pharmaceutical composition according to claim 1 further comprising: 0.5 to 3.5 mg/mL semaglutide, 1 to 2 mg/mL of phosphate buffer, and pH in the range of about 7 to about 8. 11. The liquid pharmaceutical composition according to claim 1 further comprising: 0.5 to 3.5 mg/mL semaglutide, 8.25 mg/mL sodium chloride, and 1.42 mg/mL disodium hydrogen phosphate dihydrate. 12. The liquid pharmaceutical composition according to claim 1 further comprising: histidine. 13. A kit comprising a liquid pharmaceutical composition according to claim 1, wherein the kit further comprises an injection device for administration of the composition to a subject in need of such pharmaceutical composition. 14. The kit according to claim 13, wherein the injection device comprises a needle and prefilled syringe or syringe cartridge. 15. A method of treating diabetes, obesity, Alzheimer's disease, nonalcoholic steatohepatitis (NASH) and/or cardiovascular diseases comprising administering to a subject in need thereof a therapeutically effective amount of the liquid pharmaceutical composition according to claim 1. 16. A liquid pharmaceutical composition consisting of: 0.5 to 3.5 mg/mL semaglutide, 0% (w/w) to 0.1% (w/w) phenol, buffer, 6.5 to 12 mg/mL sodium chloride, at least 60% water, optionally histidine, and optionally one or more agents for adjusting pH. 17. The liquid pharmaceutical composition according to claim 16, wherein sodium chloride is in the amount of 8.1 to 12 mg/mL. 18. The liquid pharmaceutical composition according to claim 16, wherein sodium chloride is in the amount of 8.2 to 8.9 mg/mL. 19. The liquid pharmaceutical composition according to claim 16, wherein the buffer is a phosphate buffer. 20. The liquid pharmaceutical composition according to claim 19, wherein the buffer is in the amount of 0.01 to 50 mM. 21. The liquid pharmaceutical composition according to claim 19, wherein the buffer is in the amount of 1 to 2 mg/mL. 22. A method of treating diabetes, obesity, Alzheimer's disease, nonalcoholic steatohepatitis (NASH) and/or cardiovascular diseases comprising administering to a subject in need thereof a therapeutically effective amount of the liquid pharmaceutical composition according to claim 16. 23. A liquid pharmaceutical composition consisting of: 3.2 mg/mL semaglutide, 0% (w/w) to 0.1% (w/w) phenol, 1.42 mg/mL disodium hydrogen phosphate dihydrate buffer, 8.25 mg/mL sodium chloride, pH of 7.4, at least 60% water, and optionally one or more agents for adjusting pH. 24. The liquid pharmaceutical composition according to claim 23, wherein the pharmaceutical composition is a parenteral composition. 25. The liquid pharmaceutical composition according to claim 23, wherein the pharmaceutical composition has a visual analogue scale (VAS) score below 15 on a 100 mm scale. 26. A method of treating diabetes, obesity, Alzheimer's disease, nonalcoholic steatohepatitis (NASH) and/or cardiovascular diseases comprising administering to a subject in need thereof a therapeutically effective amount of the liquid pharmaceutical composition according to claim 23.