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

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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

Brief description of study

Overview: This Phase 2a, randomized, DB, active-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of OCA (5 mg/day) administered in combination with two different BZF doses (100 and 400 mg/day) compared to BZF alone (100 and 400 mg/day) in up to 60 subjects with PBC over at least 12 weeks. Subjects will be randomized (1:1:1:1) to the following 4 treatments: Treatment A: BZF 100 mg IR; Treatment B: BZF 400 mg IR; Treatment C: OCA 5 mg + BZF 100 mg IR; and Treatment D: OCA 5 mg + BZF 400 mg IR. This study will use 100-mg and 200-mg immediate release (IR) formulation tablets of BZF.

Clinical Study Identifier: s22-00946

ClinicalTrials.gov Identifier: NCT05239468

Principal Investigator: Ira M. Jacobson.

Other Investigator: Monique Julia Carasso.

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