Oral dosing of GLP-1 compounds

Patent metadata

Field	Value
Publication number	US-12239739-B2
Application number	US-201916361971-A
Country	US
Kind code	B2
Filing date	Mar 22, 2019
Priority date	May 2, 2013
Publication date	Mar 4, 2025
Grant date	Mar 4, 2025

Abstract

The present invention relates to improved uses of glucagon-like peptide-1 (GLP-1) peptides in oral therapy.

First claim

The invention claimed is:

1. A method for treating type 2 diabetes and/or reducing body weight in a subject in need of such treatment, the method comprising:
orally administering to the subject a therapeutically effective amount of a solid oral dosage form composition comprising a glucagon-like peptide-1 (GLP-1) peptide and an enhancer,
wherein:
(a) the GLP-1 peptide is N-epsilon26-[2-(2-{2-[2-(2-{2- [(S)-4-Carboxy-4-(17-carboxyheptadecanoyl-amino) butyrylamino] ethoxy} ethoxy) acetylamino] ethoxy} ethoxy) acetyl] [Aib8,Arg34] GLP-1-(7-37) (semaglutide); and
(b) the enhancer is sodium N-(8-(2-hydroxybenzoyl) amino) caprylate (SNAC);
wherein semaglutide is the only GLP-1 peptide administered;
wherein the composition is administered daily for a period of 70 days; and
wherein the variability in plasma exposure of said GLP-1 peptide is reduced when compared to a single dose of the GLP-1 peptide.

2. The method according to claim 1 , wherein the subject is in need of treatment for both type 2 diabetes and reducing body weight.

3. The method according to claim 2 , wherein the composition comprises 200-400 mg of the SNAC.

4. The method according to claim 2 , wherein the composition comprises 2-40 mg of the semaglutide.

5. The method according to claim 4 , wherein the composition comprises 300 mg of the SNAC.

6. The method according to claim 2 , wherein the composition comprises 5-50 mg of the semaglutide.

7. The method according to claim 6 , wherein the composition comprises 300 mg of the SNAC.

8. The method according to claim 2 , wherein the composition is in the form of a tablet.

9. The method according to claim 2 , wherein the subject suffers from obesity.

10. The method according to claim 1 , wherein the subject is in need of treatment for type 2 diabetes.

11. The method according to claim 10 , wherein the composition comprises 200-400 mg of the SNAC.

12. The method according to claim 10 , wherein the composition comprises 2-40 mg of the semaglutide.

13. The method according to claim 12 , wherein the composition comprises 300 mg of the SNAC.

14. The method according to claim 13 , wherein the composition is in the form of a tablet.

15. The method according to claim 10 , wherein the composition comprises 5-50 mg of the semaglutide.

16. The method according to claim 15 , wherein the composition comprises 300 mg of the SNAC.

17. The method according to claim 16 , wherein the composition is in the form of a tablet.

18. The method according to claim 1 , wherein the patient is in need of treatment for reducing body weight.

19. The method according to claim 18 , wherein the composition comprises 200-400 mg of the SNAC.

20. The method according to claim 18 , wherein the composition comprises 2-40 mg of the semaglutide.

21. The method according to claim 20 , wherein the composition comprises 300 mg of the SNAC.

22. The method according to claim 21 , wherein the subject suffers from obesity.

23. The method according to claim 21 , wherein the composition is in the form of a tablet.

24. The method according to claim 18 , wherein the composition comprises 5-50 mg of the semaglutide.

25. The method according to claim 24 , wherein the composition comprises 300 mg of the SNAC.

26. The method according to claim 25 , wherein the subject suffers from obesity.

27. The method according to claim 25 , wherein the composition is in the form of a tablet.

Assignees

• Novo Nordisk As

Inventors

• Nielsen Flemming S
• Sauerberg Per

Classifications

• A61P3/04

  Anorexiants; Antiobesity agents · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title

• A61K31/166

  having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61K9/2054

  Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose · CPC title