NCT04594694

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

A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Obeticholic acid	5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
DRUG	Bezafibrate 200 MG	200 mg IR tablet of Bezafibrate once daily for the remainder of the study
DRUG	OCA Placebo	One tablet daily for the remainder of the study
DRUG	Bezafibrate 200 mg Placebo	One tablet daily for the remainder of the study
DRUG	Bezafibrate 400 MG	400 mg SR tablet of Bezafibrate once daily for the remainder of the study
DRUG	Bezafibrate 400 mg Placebo	One tablet daily for the remainder of the study
DRUG	OCA	OCA one tablet will be administered.
DRUG	Bezafibrate	Bezafibrate one tablet will be administered.

Timeline

• Start date: 2019-10-02
• Primary completion: 2025-10-14
• Completion: 2025-10-14
• First posted: 2020-10-20
• Last updated: 2025-11-17

Locations

33 sites across 17 countries: Australia, Belgium, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Israel, Lithuania, Netherlands, Norway, Poland, South Korea, Spain, United Kingdom