elafibranor
Sponsors
Ipsen Bioscience Inc., Ipsen Pharma, Genfit, Ipsen
Conditions
Drug-drug InteractionGeriatricsHealthyHealthy ParticipantsHealthy VolunteersHepatic ImpairmentKidney DiseasesLiver Disease
Phase 1
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
CompletedNCT03765671
Start: 2018-12-12End: 2019-06-14Updated: 2019-08-22
Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients
CompletedNCT03844555
Start: 2019-02-28End: 2020-03-21Updated: 2020-08-13
Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin
CompletedNCT03985969
Start: 2019-09-23End: 2020-03-31Updated: 2020-08-13
Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers
CompletedNCT04171752
Start: 2019-11-22End: 2020-03-30Updated: 2020-08-13
Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants
CompletedNCT05543369
Start: 2022-09-19End: 2023-03-10Updated: 2025-02-20
A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet
CompletedNCT05564208
Start: 2022-10-27End: 2023-01-14Updated: 2025-02-20
Phase 2
A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)
Active, not recruitingCTIS2024-511370-72-00
Start: 2023-03-29Target: 22Updated: 2025-12-18
A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid
Active, not recruitingCTIS2024-512232-30-00
Start: 2021-01-18Target: 61Updated: 2025-11-25
Phase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
TerminatedNCT02704403
Start: 2016-03-31End: 2020-10-28Updated: 2022-03-23
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
RecruitingNCT06016842
Start: 2023-08-31End: 2029-05-31Target: 276Updated: 2026-08-31
A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)
RecruitingCTIS2023-505251-43-00
Start: 2024-02-28Target: 124Updated: 2025-11-03
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
CompletedNCT06383403
Start: 2024-07-09End: 2026-06-16Updated: 2026-07-09
A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants with Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid
Active, not recruitingCTIS2024-510695-20-00
Start: 2024-10-15Target: 35Updated: 2026-01-09
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
Active, not recruitingNCT06730061
Start: 2025-01-16End: 2032-04-08Updated: 2026-08-31
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
RecruitingNCT07387549
Start: 2026-05-14End: 2031-05-31Target: 350Updated: 2026-08-31
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis
Not yet recruitingCTIS2026-525242-29-00
Target: 60Updated: 2026-07-23