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COMPLETEDPHASE2

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

NCT05239468•Intercept Pharmaceuticals

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•History or presence of other concomitant liver diseases
•Presence of clinical complications of PBC
•History or presence of decompensating events
•Current or history of gallbladder disease
•If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
•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.

Locations (26)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado

Coronado, California, United States

Facey Medical Group

Mission Hills, California, United States

Schiff Center for Liver Diseases / University of Miami

Miami, Florida, United States

Tampa General Medical Group

Tampa, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center Harvard Liver Research Center

Boston, Massachusetts, United States

NYU Langone Medical Center

New York, New York, United States

Key Dates

Start Date

March 21, 2022

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

September 25, 2025

Enrollment

ACTUAL participants

Conditions

Primary Biliary Cholangitis

Interventions

Bezafibrate 100 mg

DRUG

Bezafibrate 200 mg

DRUG

Obeticholic Acid 5 mg

DRUG

Obeticholic Acid placebo

DRUG

Bezafibrate Placebo

DRUG

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

NCT07304843

Primary Biliary Cholangitis (PBC)

View study

RECRUITING

Biochemical Response and Clinical Outcomes in Patients With PBC

NCT07449793

Primary Biliary Cholangitis (PBC)Primary Biliary Cholangitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

Inclusion Criteria

Exclusion Criteria

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

Biochemical Response and Clinical Outcomes in Patients With PBC

Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study

FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy