This study focuses on individuals who have primary biliary cholangitis (PBC). The purpose of the study is to determine whether obeticholic acid (OCA) in combination with an investigational drug, bezafibrate (BZF), has an effect on the patient’s PBC. OCA is a man-made version of a natural compound, bile acid, which is made in the liver. Bile acids are used by the body to help with digestion and have additional effects on liver function. OCA has been shown to improve markers of liver function when used as a single drug in subjects with PBC. Bezafibrate has been shown to decrease triglycerides and LDL cholesterol (“bad cholesterol”) and increase HDL (“good”) cholesterol. It has also been shown in some studies to have a positive effect on bile acids, liver function laboratory values, and pruritus (itching) in PBC. Researchers will assess the effects of the combination of OCA and two different doses of BZF on alkaline phosphatase (ALP; a marker of liver function) in comparison to BZF alone at two different doses. Abnormal levels of ALP in the blood could indicate issues relating to the liver, gallbladder, or bones.
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