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

About the trial

Sponsor

Ipsen

Tested

Elafibranor (drug), Placebo (other)

Dates

Started 2024-07-09; completion 2026-06-16

Results posted

Not yet

The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study d…

From ClinicalTrials.gov, last updated 2026-07-09. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Ipsen Bioscience Inc. reported $810,200 in research payments for this study in 2025 (361 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.