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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a 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). The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease. There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored. Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio). Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver). They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
Study identification
- NCT ID
- NCT06383403
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 92 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
- Jul 8, 2024
- Primary completion
- Jun 15, 2026
- Completion
- Jun 15, 2026
- Last update posted
- Jul 8, 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 Jul 8, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06383403 live on ClinicalTrials.gov.