IP Library Granted Patent US 12,458,612
Granted Patent B2
US 12,458,612 · App. 17/602,296 · Granted Nov 4, 2025

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

Inventors: Robert Walczak (Lille, FR); Vanessa Legry (Emmerin, FR); Emeline Descamps (Gondecourt, FR)
Assignee: GENFIT
A61K31/192A61K38/26A61P1/16A61P3/10
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Quick Facts
Patent No.
US 12,458,612
App. No.
17/602,296
Granted
Nov 4, 2025
Kind
B2
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.

Claims (28)

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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 28, 2021
From: WALCZAK, ROBERT; LEGRY, VANESSA; DESCAMPS, EMELINE
To: GENFIT
Reel/Frame 058486/0911 →
Priority Claims (1)
EP 19305468 · Apr 10, 2019 · regional
Continuity (1)
Related Publication 20220362187A1 · Nov 17, 2022
References Cited (34)
US 9115073B2 · Dubernet et al. · 2015 [cited by applicant]
US 11478440B2 · Walczak et al. · 2022 [cited by applicant]
US 20030022816A1 · Knudsen · 2003 [cited by examiner]
US 20170290812A1 · Darteil et al. · 2017 [cited by applicant]
US 20170290813A1 · Walczak et al. · 2017 [cited by applicant]
US 20170290814A1 · Dubernet et al. · 2017 [cited by applicant]
US 20190352715A1 · Darteil et al. · 2019 [cited by applicant]
US 20200121625A1 · Walczak et al. · 2020 [cited by applicant]
US 20200206169A1 · Walczak et al. · 2020 [cited by applicant]
US 20220056419A1 · Vidal et al. · 2022 [cited by applicant]
US 20220162702A1 · Brozek · 2022 [cited by applicant]
US 20220186313A1 · Majd · 2022 [cited by applicant]
US 20220241232A1 · Brozek et al. · 2022 [cited by applicant]
US 20220340962A1 · Majd · 2022 [cited by applicant]
US 20220401420A1 · Stankovic-Valentin et al. · 2022 [cited by applicant]
US 20220411874A1 · Darteil et al. · 2022 [cited by applicant]
US 20230039185A1 · Delhomel et al. · 2023 [cited by applicant]
US 20230296624A1 · Majd et al. · 2023 [cited by applicant]
US 20230323308A1 · Vidal et al. · 2023 [cited by applicant]
US 20240002939A1 · Hosmane et al. · 2024 [cited by applicant]
US 20240058288A1 · Shtilbans · 2024 [cited by examiner]
US 20240282454A1 · Hajji et al. · 2024 [cited by applicant]
WO WO2011064350 · 2011 [cited by applicant]
WO WO2018193006 · 2018 [cited by applicant]
WO WO2020127613 · 2020 [cited by applicant]
WO WO2023194593 · 2023 [cited by applicant]
Cariou et al. GFT505 for the treatment of nonalcoholic steatohepatitis and type 2 diabetes. Expert Opinion on Investigational Drugs. Aug. 28, 2014, vol. 23, No. 10, pp. 1441-1448. (Year: 2014). [cited by examiner]
Fiorucci, S. et al. “Future trends in the treatment of non-alcoholic steatohepatitis” [cited by applicant]
Stahl, E. P et al. “Nonalcoholic Fatty Liver Disease and the Heart” [cited by applicant]
Written Opinion in International Application No. PCT/EP2020/060283, Jul. 1, 2020, pp. 1-8. [cited by applicant]
Claims pending in U.S. Appl. No. 17/414,966, national stage of PCT/EP2019/086136, Jun. 17, 2021, pp. 1-4. [cited by applicant]
Claims pending in U.S. Appl. No. 18/378,471, filed Oct. 10, 2023, pp. 1-3. [cited by applicant]
Claims pending in U.S. Appl. No. 18/818,761, filed Aug. 29, 2024, pp. 1-3. [cited by applicant]
Kota, B. P. et al. “An overview on biological mechanisms of PPARs” [cited by applicant]