NCT05239468CompletedPhase 2
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 28 Jan 2022
- Start date
- 21 Mar 2022
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Intercept Pharmaceuticals
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT05239468
- EU CT number
- 2024-513584-77-00
- EudraCT number
- 2022-001241-20
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 72
- From 21 Mar 2022 to the primary completion date, 1 Sept 2025
- 26 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History or presence of other concomitant liver diseases
- Treatment with commercially available OCA or participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
- Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Other illness
- Current or history of gallbladder disease
Lab values
- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Other
- Presence of clinical complications of PBC
- History or presence of decompensating events
Who the study is looking for
- A definite or probable diagnosis of PBC
- Qualifying ALP and/or bilirubin liver biochemistry values
- Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Italiano La Plata Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| Hospital Universitario Austral Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| DIM Clinical Privada Coordinator of this site? Confirm its status | Ramos Mejía | Argentina | Unknown status |
| Hospital Provincial del Centenario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| The Northern Alberta Clinical Trials and Research Centre Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| University of Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Pacific Gastroenterology Associates Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Piedmont Atlanta Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Beth Israel Deaconess Medical Center Harvard Liver Research Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Gastro One Coordinator of this site? Confirm its status | Cordova | United States | Unknown status |
| Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado Coordinator of this site? Confirm its status | Coronado | United States | Unknown status |
| Methodist Clinical Research Institute (CRI) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Houston Methodist Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Gastrointestinal Associates of Northeast Tennessee Coordinator of this site? Confirm its status | Johnson City | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Schiff Center for Liver Diseases/University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Facey Medical Group Coordinator of this site? Confirm its status | Mission Hills | United States | Unknown status |
| Ochsner Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| NYU Langone Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Wake Endoscopy Center Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| American Research Corporation at the Texas Liver Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Tampa General Medical Group Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.