A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to 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 cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require 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 drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
Study identification
- NCT ID
- NCT06016842
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 276 participants
Conditions and interventions
Conditions
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
- Aug 30, 2026
2023 – 2029
United States locations
- U.S. sites
- 42
- U.S. states
- 18
- U.S. cities
- 35
| 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 | Withdrawn |
| GastroIntestinal BioSciences | Los Angeles | California | 90067 | Active, not 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 | Withdrawn |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Southwest Gastroenterology Associates, PC (SWGA) | Albuquerque | New Mexico | 87109 | Terminated |
| 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 | Terminated |
| 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 | Active, not recruiting |
| Gastro health & Nutrition | Katy | Texas | 77904 | Terminated |
| American Research Corporation at The Texas Liver Institute | San Antonio | Texas | 78015 | Recruiting |
| Impact Research Tx | Waco | Texas | 76710 | Withdrawn |
| 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 |
| University Physicians and Surgeons Inc, dba Marshall Health | Huntington | West Virginia | 25701 | 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 144 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 Aug 30, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06016842 live on ClinicalTrials.gov.