Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

This study is testing the combination of fenofibrate and ursodeoxycholic acid (UDCA) as a treatment for Primary Biliary Cholangitis (PBC) — a chronic autoimmune liver disease in which the bile ducts inside the liver are progressively destroyed, eventually leading to cirrhosis. UDCA is the established first-line treatment for PBC, but many patients have an incomplete response. Fenofibrate, a lipid-lowering drug, activates PPAR-alpha, a receptor that reduces bile acid synthesis and liver inflammation, and may work synergistically with UDCA to normalize liver enzymes and slow disease progression. To participate, you must be between 18 and 75 years old, have a confirmed PBC diagnosis, have a BMI between 17 and 28 kg/m2, and have an incomplete response to UDCA (elevated ALP or other liver tests after 4–6 weeks of UDCA treatment). You cannot participate if you have other liver diseases, severely elevated liver enzymes (ALT/AST above 5x normal), are pregnant or breastfeeding, are allergic to either study drug, are taking hepatotoxic medications, have variceal bleeding or uncontrolled liver failure complications, or have severe kidney, heart, or cerebrovascular disease. Participants will receive fenofibrate added to their existing UDCA therapy and be followed for liver enzyme normalization and safety. This research is important because PBC without adequate treatment progression can lead to liver failure and the need for transplant. Finding an effective and safe combination therapy for those who don't respond adequately to UDCA alone could dramatically change the prognosis for these patients.