A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
Public ClinicalTrials.gov record NCT06383403. 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 IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
Study identification
- NCT ID
- NCT06383403
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Ipsen
- Industry
- Enrollment
- 69 participants
Conditions and interventions
Conditions
Interventions
- Elafibranor Drug
- 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
- Jul 8, 2024
- Primary completion
- Jun 25, 2026
- Completion
- Jun 25, 2026
- Last update posted
- Apr 29, 2026
2024 – 2026
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92118 | — |
| Topgraphy Health, Inc. | Los Angeles | California | 90005 | — |
| University of California, Davis | Sacramento | California | 95616 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80135 | — |
| Rocky Mountain Gastroenterology | Littleton | Colorado | 80120 | — |
| International Center for Research | Tampa | Florida | 33614 | — |
| Delta Research Partners, LLC | West Monroe | Louisiana | 71291 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Huron Gastroenterology Associates - Center for Digestive Care | Ypsilanti | Michigan | 48197 | — |
| South Denver Gastroenterology,P.C. | Englewood | New Jersey | 80113 | — |
| Southwest Gastroenterology Associates, PC (SWGA) | Albuquerque | New Mexico | 87109 | — |
| Northwell Health Center for Liver Disease and Transplantation | Manhasset | New York | 11030 | — |
| Charlotte Gastroenterology & Hepatology, PLLC | Charlotte | North Carolina | 28277 | — |
| Coastal Research Institute | Fayetteville | North Carolina | 28304 | — |
| Gastroenterology Center of the Midsouth | Cordova | Tennessee | 38018 | — |
| Methodist Transplant Physicians | Dallas | Texas | 75203 | — |
| American Research Corporation at The Texas Liver Institute | San Antonio | Texas | 78215 | — |
| American Research Corporation | San Antonio | Texas | 78215 | — |
| Velocity Liver Institute NW | Seattle | Washington | 98105 | — |
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 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06383403, 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
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06383403 live on ClinicalTrials.gov.