Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Status:
Recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
Summary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver
disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and
eventual cirrhosis requiring liver transplantation or resulting in death. The investigational
drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the
primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including
its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its
hepatoprotective effects and result in attenuation of injury and improved liver function in a
cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to
placebo, combined with stable standard care, on clinical outcomes in PBC patients.