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

The main purpose of this study is to assess the effects of the combination of a drug called Obeticholic Acid (OCA) and two different doses of another drug called Bezafibrate (BZF) on alkaline phosphatase (ALP; a marker of liver function) in comparison to BZF alone at two different doses, in people who have Primary Biliary Cholangitis (PBC). Abnormal levels of ALP in the blood could indicate issues relating to the liver, gallbladder, or bones. PBC is a rare autoimmune liver disease that causes progressive destruction of the bile ducts.

Clinical Study Identifier: s22-00946
ClinicalTrials.gov Identifier: NCT05239468
Principal Investigator: Ira M. Jacobson.
Other Investigator: Monique Julia Carasso.

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