This study focuses on Primary Biliary Cholangitis (PBC), a long-term liver disease that causes the bile ducts in the liver to become damaged. The study will test a medication called seladelpar in patients who have PBC with compensated cirrhosis, which means scarring of the liver that is still functioning. The purpose is to determine if seladelpar can improve health outcomes in these patients compared to placebo.

The medication will be given as oral capsules in two different strengths – 5 mg and 10 mg. The study will last for 156 weeks (about 3 years). During this time, researchers will monitor various aspects of liver health and complications that can occur with liver disease, such as ascites (fluid buildup in the abdomen), hepatic encephalopathy (brain function problems caused by liver disease), and esophageal varices (enlarged veins in the food pipe that can bleed).

This is a randomized, double-blind study, which means that patients will be assigned by chance to receive either seladelpar or placebo. Neither the patients nor the doctors will know which treatment each person is receiving. The study will track important health events including survival, need for liver transplantation, and hospitalizations related to liver complications. The medication’s safety will also be carefully monitored throughout the study period.