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

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).

Timeline

Start

2022-03-21

Primary completion

2025-09-01

Completion

2025-09-01

Outcome

Mixed primary results

registry Placebo + BZF 100 mg vs OCA 5 mg + BZF 100 mg; p = 0.003; Least square mean difference -44.7 NCT05239468 ↗

registry Placebo + BZF 400 mg vs OCA 5 mg + BZF 400 mg; p = 0.058; Least square mean difference -20.4 (95% CI -41.6 to 0.8) NCT05239468 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bezafibrate	Small molecule	100 mg	Oral
Subject	Bezafibrate	Small molecule	400 mg	Oral
Subject	Obeticholic Acid	Small molecule	5 mg	Oral

Indications