To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Public ClinicalTrials.gov record NCT06488911. 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 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis
Study identification
- NCT ID
- NCT06488911
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Intercept Pharmaceuticals
- Industry
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Interventions
- FDC tablet (OCA 5 mg + BZF 400 mg SR) Drug
Drug
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
- Jun 30, 2024
- Primary completion
- Oct 20, 2025
- Completion
- Oct 20, 2025
- Last update posted
- Jun 7, 2026
2024 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| Tampa General Medical Group | Tampa | Florida | 33606 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| East Tennessee Research Institute | Johnson City | Tennessee | 37604 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| American Research Corporation | San Antonio | Texas | 78215 | — |
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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06488911, 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 Jun 7, 2026 · Synced Jul 22, 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 NCT06488911 live on ClinicalTrials.gov.