To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

Stopped early · Phase 3

Conditions studied: Primary Biliary Cholangitis

In brief

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Key facts

Study ID

NCT06488911

Run by

Intercept Pharmaceuticals

People needed

62

Starts

2024-07-01

Expected to finish

2025-10-21

Last updated by the study team

2026-06-08

Who can join

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

You may qualify if…

• All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).

You may not qualify if…

• History or presence of other concomitant liver diseases
• Clinical complications of PBC
• History or presence of hepatic 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.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Southern California Research Center — Coronado, California, United States
• Tampa General Medical Group — Tampa, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• NYU Langone Health — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Gastro One — Germantown, Tennessee, United States
• East Tennessee Research Institute — Johnson City, Tennessee, United States
• The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• American Research Corporation — San Antonio, Texas, United States
• DIM Clinica Privada — Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• Hospital Italiano de La Plata — Buenos Aires, Argentina
• Hospital Universitario Austral — Buenos Aires, Argentina
• Hospital Provincial del Centenario — Santa Fe, Argentina
• Royal Adelaide Hospital — Adelaide, Australia
• Flinders Medical Centre — Bedford Park, Australia
• UZ Leuven — Leuven, Belgium
• University of Alberta Division of Gastroenterology Zeidler Ledcor Centre — Edmonton, Alberta, Canada
• Pacific Gastroenterology Associates GI Research Institute — Vancouver, British Columbia, Canada
• Universityl Hospital Dubrava — Zagreb, Croatia
• Hepato-Gastroenterologie HK, s.r.o. — Hradec Králové, Czechia
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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