Clinical Trial

Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

Active, Not Recruiting Phase 2
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Summary
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-01-30; most recent amendment 2026-06-24.
Status change: Recruiting → Active, Not Recruiting 2025-05-22
Trial Details
NCT Number NCT06247735
Lead Sponsor Kowa Research Institute, Inc.
Conditions Primary Biliary Cholangitis
Enrollment 46 participants
Start Date 2024-02-07
Primary Completion 2025-06-26 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-26