Phase 2Completed

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

Sponsor

Kowa Research Institute, Inc. (Industry)

Enrolment

46 enrolled

Conditions

Primary Biliary Cholangitis

Interventions

K-808 (Dose A); K-808 (Dose B); Placebo

Ages

adults, older adults

Registry

NCT06247735

Full record on ClinicalTrials.gov