A Phase 2 Randomized Placebo-controlled Parallel Group Multicenter 12-week Study with a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects with Primary Biliary Cholangitis with Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment

Brief description of study

This study will look at a study drug, called K-808, for participants with a liver condition called primary biliary cholangitis (PBC).

PBC is defined by damage to the bile ducts in the liver, which causes liver damage. Bile is a fluid made in your liver. It helps with digestion, helps you absorb nutrients, and helps your body get rid of toxins and waste. Bile ducts are tiny canals in which bile moves inside your liver and then is delivered to your digestive system. Due to damage to the bile ducts caused by PBC, the liver does not work as well. If left untreated, PBC can lead to liver fibrosis (scarring of the liver) and its problems, which include liver failure and liver cancer.

The purpose of the study is to find out whether K-808 works and how safe it is in participants with PBC. To answer these questions, K-808 will be compared with a placebo. A placebo is a tablet that looks just like the K 808 study drug but contains no active drug.


Clinical Study Identifier: s24-00093
ClinicalTrials.gov Identifier: NCT06247735
Principal Investigator: Ira M. Jacobson.
Other Investigators: Monique Julia Carasso, David Fixler, Nina M Gardner, Flordelis Cruz Reyes.


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