NCT06247735

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.

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	K-808 (Dose A)	Administered orally once daily
DRUG	K-808 (Dose B)	Administered orally once daily
DRUG	Placebo	Administered orally once daily

Timeline

• Start date: 2024-02-07
• Primary completion: 2025-06-26
• Completion: 2026-06-01
• First posted: 2024-02-08
• Last updated: 2025-09-10

Locations

38 sites across 3 countries: United States, Canada, Japan

Regulatory

• FDA-regulated drug study