NCT05239468

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Bezafibrate 100 mg	One tablet of bezafibrate 100 mg IR once daily
DRUG	Bezafibrate 200 mg	Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
DRUG	Obeticholic Acid 5 mg	One tablet of obeticholic acid 5 mg tablet once daily.
DRUG	Obeticholic Acid placebo	One tablet of obeticholic acid placebo tablet once daily
DRUG	Bezafibrate Placebo	One tablet of bezafibrate placebo tablet once daily

Timeline

• Start date: 2022-03-21
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-02-15
• Last updated: 2025-09-25

Locations

26 sites across 4 countries: United States, Argentina, Canada, Italy

Regulatory

• FDA-regulated drug study