Combination therapy comprising compounds of formula (I) and GLP-1 receptor agonists

Patent metadata

Field	Value
Publication number	US-12458612-B2
Application number	US-202017602296-A
Country	US
Kind code	B2
Filing date	Apr 9, 2020
Priority date	Apr 10, 2019
Publication date	Nov 4, 2025
Grant date	Nov 4, 2025

Abstract

The present invention relates to a combination therapy comprising a PPAR agonist, such as elafibranor, and a GLP-1 receptor agonist, such as semaglutide, liraglutide, exenatide, lixisenatide, albiglutide and dulaglutide, for the treatment of a condition is selected from the group consisting of non-alcoholic fatty liver disease, diabetes and obesity.

First claim

The invention claimed is:

1 . A method for treating a condition for which the administration of a GLP-1 receptor agonist is needed comprising the administration of a combination product to a subject in need thereof,
wherein the condition is selected from the group consisting of non-alcoholic fatty liver disease, diabetes and obesity, and wherein the combination product comprises: (i) elafibranor or a pharmaceutically acceptable salt thereof; and (ii) a Glucagon-like peptide-1 (GLP-1) receptor agonist selected from the group consisting of semaglutide, liraglutide and a pharmaceutically acceptable salt thereof, wherein the amount of Glucagon-like peptide-1 (GLP-1) receptor agonist that is administered is reduced at least 1.5-fold as compared to the amount of GLP-1 agonist required when administered alone.

2 . The method according to claim 1 , wherein at least one side effect of the GLP-1 receptor agonist is reduced.

3 . A method for the reduction of body weight comprising the administration of a combination product to a subject in need thereof, wherein the combination product comprises:
(i) elafibranor or a pharmaceutically acceptable salt thereof; and (ii) a Glucagon-like peptide-1 (GLP-1) receptor agonist selected from the group consisting of semaglutide, liraglutide and a pharmaceutically acceptable salt thereof, wherein the amount of Glucagon-like peptide-1 (GLP-1) receptor agonist that is administered is reduced at least 1.5-fold as compared to the amount of GLP-1 agonist required when administered alone.

4 . A method for the treatment of a condition for which the administration of a GLP-1 receptor agonist is needed comprising the administration of a combination product to a subject in need thereof, wherein the amount of GLP-1 receptor agonist administered is reduced at least 1.5-fold as compared to the amount of GLP-1 receptor agonist required when the GLP-1 receptor agonist is administered alone and wherein the combination product comprises:
(i) elafibranor or a pharmaceutically acceptable salt thereof; and (ii) a Glucagon-like peptide-1 (GLP-1) receptor agonist selected from the group consisting of semaglutide, liraglutide and a pharmaceutically acceptable salt thereof.

5 . A method for the treatment of a condition for which the administration of a GLP-1 receptor agonist is needed comprising the administration of a combination product to a subject in need thereof, wherein at least one adverse effect associated to GLP-1 receptor agonist is reduced as compared to when the GLP-1 receptor agonist is administered alone, wherein the combination product comprises:
(i) elafibranor or a pharmaceutically acceptable salt thereof; and (ii) a Glucagon-like peptide-1 (GLP-1) receptor agonist selected from the group consisting of semaglutide, liraglutide and a pharmaceutically acceptable salt thereof, wherein the amount of Glucagon-like peptide-1 (GLP-1) receptor agonist that is administered is reduced at least 1.5-fold as compared to the amount of GLP-1 agonist required when administered alone.

6 . The method according to claim 1 , wherein component (i) is elafibranor.

7 . The method according to claim 1 , wherein component (ii) is semaglutide or liraglutide.

8 . The method according to claim 7 , wherein component (ii) is semaglutide or a pharmaceutically acceptable salt thereof.

9 . The method according to claim 7 , wherein component (ii) is liraglutide or a pharmaceutically acceptable salt thereof.

10 . The method according to claim 1 , wherein the combination product is a composition comprising components (i) and (ii) and a pharmaceutically acceptable carrier.

11 . The method according to claim 1 , wherein components (i) and (ii) are formulated in a suspension, a gel, an oil, a pill, a tablet, a suppository, a powder, a capsule, an aerosol, an ointment, a cream, a patch, or a means of galenic forms for a prolonged and/or slow release.

12 . The method according to claim 1 , wherein the combination product is a kit of parts comprising components (i) and (ii), for sequential, separate or simultaneous use.

13 . The method according to claim 12 , wherein components (i) and (ii) are oral dosage forms.

14 . The method according to claim 12 , wherein components (i) and (ii) are pills or tablets as oral dosage forms.

15 . The method according to claim 12 , wherein component (i) is an oral dosage form and component (ii) is an injectable solution.

Assignees

• Genfit

Inventors

• Walczak Robert
• Legry Vanessa
• Descamps Emeline

Classifications

• A61K38/26

  Glucagons · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61P1/16

  for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K9/20

  Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)} · CPC title