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elafibranor

DRUG16 trials

Sponsors

Ipsen Bioscience Inc., Ipsen Pharma, Genfit, Ipsen

Conditions

Drug-drug InteractionGeriatricsHealthyHealthy ParticipantsHealthy VolunteersHepatic ImpairmentKidney DiseasesLiver Disease

Phase 1

Phase 2

Phase 3

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
TerminatedNCT02704403
GenfitNonalcoholic Steatohepatitis (NASH) With Fibrosis
Start: 2016-03-31End: 2020-10-28Updated: 2022-03-23
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
RecruitingNCT06016842
IpsenPrimary Biliary Cholangitis (PBC)
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
Ipsen Bioscience Inc.Primary Biliary Cholangitis
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
IpsenPrimary Biliary Cholangitis
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
Ipsen Bioscience Inc.Primary Biliary Cholangitis (PBC)
Start: 2024-10-15Target: 35Updated: 2026-01-09
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
Active, not recruitingNCT06730061
IpsenPrimary Biliary Cholangitis
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
IpsenPrimary Sclerosing Cholangitis
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
Ipsen Bioscience Inc.Primary Sclerosing Cholangitis
Target: 60Updated: 2026-07-23

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