A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Public ClinicalTrials.gov record NCT07387549. 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, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death. In this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up. During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety. Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.
Study identification
- NCT ID
- NCT07387549
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- May 13, 2026
- Primary completion
- Apr 29, 2031
- Completion
- May 30, 2031
- Last update posted
- Aug 30, 2026
2026 – 2031
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Liver Health | Chandler | Arizona | 85224 | Recruiting |
| Southern California Research Center | Coronado | California | 92118 | Recruiting |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80920 | Recruiting |
| South Denver Gastroenterology,P.C. | Englewood | Colorado | 80113 | Recruiting |
| Rocky Mountain Gastroenterology (RMG) | Littleton | Colorado | 90046 | Recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Recruiting |
| Mercy Medical Center, Inc | Baltimore | Maryland | 21202 | Recruiting |
| University Gastroenterology | Providence | Rhode Island | 02904 | Recruiting |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | Recruiting |
| Gastrointestinal Associates of Northeast Tennessee | Johnson City | Tennessee | 37604 | Recruiting |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | Recruiting |
| American Research Corporation at The Texas Liver Institute | San Antonio | Texas | 78215 | Recruiting |
| Velocity Clinical Research, Seattle | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07387549, 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 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07387549 live on ClinicalTrials.gov.