NCT06488911

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

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	FDC tablet (OCA 5 mg + BZF 400 mg SR)	Participants will be administered with FDC tablets once daily.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-10-21
• Completion: 2025-10-21
• First posted: 2024-07-05
• Last updated: 2025-10-31

Locations

51 sites across 21 countries: United States, Argentina, Australia, Belgium, Canada, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Norway, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study