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

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Biliary Cholangitis

In brief

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).

Key facts

Study ID

NCT05239468

Run by

Intercept Pharmaceuticals

People needed

72

Starts

2022-03-21

Expected to finish

2025-09-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• 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
• Wake Endoscopy Center — Raleigh, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Gastro One — Cordova, Tennessee, United States
• Gastrointestinal Associates of Northeast Tennessee — Johnson City, Tennessee, United States
• Methodist Clinical Research Institute (CRI) — Dallas, Texas, United States
• Houston Methodist Cancer Center — Houston, Texas, United States
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States
• Hospital Italiano La Plata — La Plata, Buenos Aires, Argentina
• DIM Clinical Privada — Ramos Mejía, Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• Hospital Universitario Austral — Pilar, Argentina
• Hospital Provincial del Centenario — Rosario, Argentina
• The Northern Alberta Clinical Trials and Research Centre — Edmonton, Alberta, Canada
• Pacific Gastroenterology Associates — Vancouver, British Columbia, Canada
• University of Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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