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Completed Phase 2 Interventional

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.

ClinicalTrials.gov ID: NCT06247735

Public ClinicalTrials.gov record NCT06247735. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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 summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT06247735
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Kowa Research Institute, Inc.
Industry
Enrollment
46 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 7, 2024 (Actual)
Primary completion
Jun 26, 2025 (Actual)
Completion
Jul 23, 2026 (Actual)
Last update posted
Oct 7, 2026

2024 – 2026

United States locations

U.S. sites
21
U.S. states
16
U.S. cities
21
Facility City State ZIP Site status
UA Thomas D. Boyer Liver Institute Tucson Arizona 85724 —
Southern California Research Center - Coronado Coronado California 92118 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Velocity Clinical Research Santa Ana California 92704 —
Peak Gastroenterology Associates Colorado Springs Colorado Springs Colorado 80921 —
University of Florida Hepatology Research at CTRB Gainesville Florida 32610 —
Florida Research Institute Lakewood Rch Florida 34211 —
University of Miami Leonard M. Miller School of Medicine Miami Florida 33136 —
Springfield Clinic Springfield Illinois 62702 —
Mercy Medical Center - Mcauley Plaza Baltimore Maryland 21202 —
CommonSpirit Health Research Institute Omaha Nebraska 68124 —
New York University Hepatology Associates New York New York 10016 —
Wake Forest University Baptist Medical Center Winston-Salem North Carolina 27157 —
University of Cincinnati Cincinnati Ohio 45267 —
Einstein Medical Center Philadelphia Pennsylvania 19141 —
Rapid City Medical Center Rapid City South Dakota 57701 —
Vanderbilt Digestive Disease Center Nashville Tennessee 37232 —
Pioneer Research Solutions Houston Texas 77099 —
UVA Health - University of Virginia Health System Charlottesville Virginia 22908 —
Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists Norfolk Virginia 23502 —
Liver Institute Northwest Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06247735, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 7, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06247735 live on ClinicalTrials.gov.

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