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Elafibranor

Generic Name
Elafibranor
Brand Names
Iqirvo
Drug Type
Small Molecule
Chemical Formula
C22H24O4S
CAS Number
923978-27-2
Unique Ingredient Identifier
2J3H5C81A5
Background

Elafibranor (code name GFT505) is a multimodal and pluripotent medication for treatment of atherogenic dyslipidemia for an overweight patient with or without diabetes. It is an oral treatment that acts on the 3 sub-types of PPAR (PPARa, PPARg, PPARd) with a preferential action on PPARa. As of February 2016, elafibranor has completed 8 clinical trials and a phase III is in progress.

Indication

Investigated for use/treatment in atherosclerosis and diabetes mellitus type 2.

Clinical Trials
Related News

A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

Phase 3
Recruiting
Conditions
Primary Biliary Cholangitis
Interventions
First Posted Date
2024-12-12
Last Posted Date
2025-05-01
Lead Sponsor
Ipsen
Target Recruit Count
18
Registration Number
NCT06730061
Locations
🇯🇵

Nippon Medical School - Chiba Hokusoh Hospital, Chiba, Japan

🇯🇵

Kagoshima University Hospital, Kagoshima, Japan

🇯🇵

Shinshu University Hospital, Nagano, Japan

and more 13 locations

A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Phase 3
Active, not recruiting
Conditions
Primary Biliary Cholangitis
Interventions
Other: Placebo
First Posted Date
2024-04-25
Last Posted Date
2025-05-01
Lead Sponsor
Ipsen
Target Recruit Count
69
Registration Number
NCT06383403
Locations
🇨🇿

Institute for Clinical and Experimental Medicine - IKEM, Prague, Czechia

🇨🇿

Research Site s.r.o., Plzen, Czechia

🇩🇪

Universitaetsklinikum Muenster, Münster, Germany

and more 57 locations

A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

Phase 3
Recruiting
Conditions
Primary Biliary Cholangitis (PBC)
Interventions
Other: Matched 80 mg placebo
First Posted Date
2023-08-30
Last Posted Date
2025-04-30
Lead Sponsor
Ipsen
Target Recruit Count
276
Registration Number
NCT06016842
Locations
🇧🇪

Gent University Hospital, Gent, Belgium

🇧🇪

Algemeen Ziekenhuis Delta, Roeselare, Belgium

🇧🇷

Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre, Brazil

and more 128 locations

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

Phase 2
Active, not recruiting
Conditions
Primary Sclerosing Cholangitis
Interventions
Drug: Placebo Matched to Elafibranor 120 mg
Drug: Placebo Matched to Elafibranor 80 mg
First Posted Date
2022-11-25
Last Posted Date
2025-05-01
Lead Sponsor
Ipsen
Target Recruit Count
68
Registration Number
NCT05627362
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Piedmont Hospital - Piedmont Transplant Institute, Atlanta, Georgia, United States

🇬🇧

Aberdeen Royal Infirmary NHS Grampian Grampian Health Board, Aberdeen, United Kingdom

and more 59 locations

A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2022-10-03
Last Posted Date
2025-02-20
Lead Sponsor
Ipsen
Target Recruit Count
34
Registration Number
NCT05564208
Locations
🇫🇷

BIOTRIAL, Rennes, France

Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2022-09-16
Last Posted Date
2025-02-20
Lead Sponsor
Ipsen
Target Recruit Count
48
Registration Number
NCT05543369
Locations
🇺🇸

Collaborative Neuroscience Research LLC, Long Beach, California, United States

🇺🇸

Collaborative Neuroscience Research, LLC, Los Alamitos, California, United States

Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

Phase 3
Active, not recruiting
Conditions
Primary Biliary Cirrhosis
Interventions
Drug: Placebo
First Posted Date
2020-08-26
Last Posted Date
2025-04-30
Lead Sponsor
Ipsen
Target Recruit Count
161
Registration Number
NCT04526665
Locations
🇺🇸

Keck Medical Center of USC, Los Angeles, California, United States

🇺🇸

Henry Ford Health System, Novi, Michigan, United States

🇿🇦

Tiervlei Trial Centre, Cape Town, Western Cape, South Africa

and more 112 locations

Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers

Phase 1
Completed
Conditions
Geriatrics
Healthy
Interventions
First Posted Date
2019-11-21
Last Posted Date
2020-08-13
Lead Sponsor
Genfit
Target Recruit Count
21
Registration Number
NCT04171752
Locations
🇫🇷

BIOTRIAL, Rennes, France

Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin

Phase 1
Completed
Conditions
Drug-drug Interaction
Interventions
Drug: CHRONO-INDOCID
First Posted Date
2019-06-14
Last Posted Date
2020-08-13
Lead Sponsor
Genfit
Target Recruit Count
26
Registration Number
NCT03985969
Locations
🇫🇷

Eurofins Optimed Clinical Pharmacology Unit, Gières, France

Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)

Phase 2
Terminated
Conditions
Non-Alcoholic Fatty Liver
Interventions
Drug: Placebo
First Posted Date
2019-05-16
Last Posted Date
2020-08-31
Lead Sponsor
Genfit
Target Recruit Count
17
Registration Number
NCT03953456
Locations
🇳🇱

NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, Netherlands

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