This study focuses on individuals who are 18-75 years old and have a confirmed diagnosis of primary biliary cholangitis (PBC). PBC is a progressive inflammatory disease leading to destruction of the bile ducts and scarring of the liver. The purpose of the study is to explore the treatment effect of an investigational drug called saroglitazar magnesium (saroglitazar) as a possible treatment for PBC. Previous studies suggest that saroglitazar may improve liver enzymes and lipid profiles in people with PBC. Researchers will evaluate the effectiveness and safety of saroglitazar’s optimal dose and placebo (inactive substance) in patients with PBC.
What is the full name of this clinical trial?
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis