New hope for bile duct disease: experimental drug K-808 tested in patients failed by standard care

NCT ID NCT06247735

Ongoing Disease control Sponsor: Kowa Research Institute, Inc. Source: ClinicalTrials.gov ↗

First seen Nov 01, 2025 · Last updated May 15, 2026 · Updated 31 times

Summary

This study tests whether a new drug called K-808 (Pemafibrate) can improve liver health in people with primary biliary cholangitis (PBC), a chronic liver disease. The trial includes 46 adults whose disease did not respond well to standard medications. Participants receive either K-808 or a placebo for 12 weeks, with a longer follow-up to check safety and effectiveness.

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Contacts and locations

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Locations

(G.I,R,I) GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada
302

Sapporo, Japan
303

Itabashi-ku, Japan
304

Isehara, Japan
305

Hamamatsu, Japan
306

Fukui, Japan
307

Matsumoto, Japan
308

Hirakata, Japan
309

Hiroshima, Japan
311

Ōmura, Japan
312

Kanazawa, Japan
313

Fukuoka, Japan
314

Yokohama, Japan
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

Montreal, Quebec, H2X 0A9, Canada
CommonSpirit Health Research Institute

Omaha, Nebraska, 68124, United States
Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States
Florida Research Institute

Lakewood Rch, Florida, 34211, United States
Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States
Liver Institute Northwest

Seattle, Washington, 98105, United States
Mercy Medical Center - Mcauley Plaza

Baltimore, Maryland, 21202, United States
New York University Hepatology Associates

New York, New York, 10016, United States
Office of Dr. Gauthier

North Bay, Ontario, P1B 2H3, Canada
Peak Gastroenterology Associates Colorado Springs

Colorado Springs, Colorado, 80921, United States
Pioneer Research Solutions

Houston, Texas, 77099, United States
Rapid City Medical Center

Rapid City, South Dakota, 57701, United States
Southern California Research Center - Coronado

Coronado, California, 92118, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Teine Keijinkai Hospital

Sapporo, Japan
Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada
UA Thomas D. Boyer Liver Institute

Tucson, Arizona, 85724, United States
UVA Health - University of Virginia Health System

Charlottesville, Virginia, 22908, United States
University of Cincinnati

Cincinnati, Ohio, 45267, United States
University of Florida Hepatology Research at CTRB

Gainesville, Florida, 32610, United States
University of Miami Leonard M. Miller School of Medicine

Miami, Florida, 33136, United States
Vanderbilt Digestive Disease Center

Nashville, Tennessee, 37232, United States
Velocity Clinical Research

Santa Ana, California, 92704, United States
Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Conditions

Explore the condition pages connected to this study.

PRIMARY BILIARY CHOLANGITIS