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

ClinicalTrials.gov ID: NCT06016842

Public ClinicalTrials.gov record NCT06016842. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 19, 2026, 11:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID: NCT06016842
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Ipsen; Industry
Enrollment: 276 participants

Conditions and interventions

Conditions

Primary Biliary Cholangitis (PBC)

Interventions

Elafibranor Drug
Matched 80 mg placebo Other

Drug · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 30, 2023
Primary completion: May 30, 2029
Completion: May 30, 2029
Last update posted: Apr 29, 2026

2023 – 2029

United States locations

U.S. sites: 40
U.S. states: 16
U.S. cities: 33

Facility	City	State	ZIP	Site status
Arizona Liver Health	Tucson	Arizona	85641	Recruiting
Arkansas Diagnostic Center, PA	Little Rock	Arkansas	55130	Terminated
Southern California Research Center	Coronado	California	92118	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	90048	Recruiting
GastroIntestinal BioSciences	Los Angeles	California	90067	Recruiting
University of California Los Angeles	Los Angeles	California	90404	Withdrawn
University of California Davis Medical Center	Sacramento	California	95817	Recruiting
University of Colorado	Aurora	Colorado	80045	Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	80829	Recruiting
South Denver Gastroenterology, P.C.	Englewood	Colorado	80113	Recruiting
Rocky Mountain Gastroenterology	Littleton	Colorado	80120	Recruiting
University Of Miami School Of Medicine, Center For Liver Diseases	Miami	Florida	33136	Recruiting
Bolanos Clinical Research	Pembroke Pines	Florida	12105	Recruiting
International Center for Research	Tampa	Florida	33614	Recruiting
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic	Kansas City	Kansas	66160	Not yet recruiting
Louisiana Research Center, LLC	Shreveport	Louisiana	71103	Recruiting
University of Michigan Health System	Ann Arbor	Michigan	48109	Recruiting
Huron Gastroenterology Associates - Center for Digestive Care	Ypsilanti	Michigan	48197	Active, not recruiting
Southwest Gastroenterology Associates, PC (SWGA)	Albuquerque	New Mexico	87109	Active, not recruiting
NYU Langone Gastroenterology and Hepatology Associates	New York	New York	10016	Recruiting
University of Pittsburgh	Pittsburgh	Pennsylvania	15213	Recruiting
Medical University of South Carolina	Charleston	South Carolina	29425	Recruiting
Gastroenterology Center of the Midsouth	Cordova	Tennessee	38138	Recruiting
Texas Clinical Research Institute	Arlington	Texas	22201	Recruiting
American Research Corporation	Austin	Texas	78757	Recruiting
Rush University Medical Center - University Cardiovascular Surgeons	Dallas	Texas	60612	Withdrawn
Liver Center of Texas	Dallas	Texas	75203	Recruiting
Methodist Transplant Physicians	Dallas	Texas	75203	Recruiting
University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	75390	Recruiting
Baylor Scott & White All Saints Medical Center - Forth Worth	Fort Worth	Texas	76104	Withdrawn
Liver Associates of Texas	Houston	Texas	77030	Recruiting
Houston Methodist Cancer Center	Houston	Texas	77584	Recruiting
Gastro health & Nutrition	Katy	Texas	77904	Withdrawn
American Research Corporation at The Texas Liver Institute	San Antonio	Texas	78015	Recruiting
Impact Research Tx	Waco	Texas	76710	Recruiting
University of Virginia Medical Center	Charlottesville	Virginia	22903	Recruiting
Bon Secours St. Mary's Hospital of Richmond, Inc	Richmond	Virginia	23226	Recruiting
Virginia Commonwealth University Medical Center - West Hospital	Richmond	Virginia	23298	Not yet recruiting
Medstar Georgetown Transplant Institute University Hospital (MGUH)	Columbia	Washington	20007	Withdrawn
Velocity Clinical Research at Liver Institute Northwest	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 140 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06016842, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 29, 2026 · Synced May 19, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06016842 live on ClinicalTrials.gov.

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