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New hope for PBC patients: experimental drug K-808 enters Mid-Stage trial

NCT ID NCT06247735

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two doses of K-808 (Pemafibrate) in 46 adults with primary biliary cholangitis (PBC) who haven't responded well to standard treatments. The main goal is to see if the drug lowers alkaline phosphatase (ALP) levels, a key marker of liver damage, after 12 weeks. Participants will be followed for up to a year to check safety and long-term effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Pemafibrate (K-808)

What this could lead to

If successful, this could offer a new treatment option for people with primary biliary cholangitis who don't respond well to current therapies.

What could go wrong

This is an early Phase 2 trial with only 46 participants, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PRIMARY BILIARY CHOLANGITIS

Contacts and locations

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