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A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
NCT06016842 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Elafibranor
- OTHER Matched 80 mg placebo
Study Locations (20)
California
- Southern California Research Center — Coronado
- Cedars-Sinai Medical Center — Los Angeles
- GastroIntestinal BioSciences — Los Angeles
- University of California Los Angeles — Los Angeles
- University of California Davis Medical Center — Sacramento
Colorado
- University of Colorado — Aurora
- Peak Gastroenterology Associates — Colorado Springs
- South Denver Gastroenterology, P.C. — Englewood
- Rocky Mountain Gastroenterology — Littleton
Florida
- University Of Miami School Of Medicine, Center For Liver Diseases — Miami
- Bolanos Clinical Research — Pembroke Pines
- International Center for Research — Tampa
Michigan
- University of Michigan Health System — Ann Arbor
- Huron Gastroenterology Associates - Center for Digestive Care — Ypsilanti
Arizona
- Arizona Liver Health — Tucson
Arkansas
- Arkansas Diagnostic Center, PA — Little Rock
Kansas
- University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic — Kansas City
Louisiana
- Louisiana Research Center, LLC — Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06016842
The ClinicalTrials.gov registry entry for NCT06016842 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Biliary Cholangitis (PBC) appearing as the primary indexed condition, and to 2 interventions — of which Elafibranor is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06016842 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06016842 about?
NCT06016842 is a clinical study titled "A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis". 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...
What is the current status of trial NCT06016842?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2023-08-31. Estimated completion is 2029-05-31.
What conditions does trial NCT06016842 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis (PBC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06016842?
The interventions under investigation include: Elafibranor (DRUG), Matched 80 mg placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06016842?
This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06016842 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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