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New drug aimed at slowing liver damage in rare bile duct disease

NCT ID NCT04480840

Disease control Sponsor: Pliant Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This Phase 2a trial tested an experimental oral drug called PLN-74809 in 121 adults with primary sclerosing cholangitis (PSC) and suspected liver fibrosis. The main goals were to check the drug's safety and how it moves through the body. Participants received either the drug or a placebo for up to 24 weeks. The study is complete, but results on effectiveness are not yet available.

What this could mean

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

Active substance
PLN-74809 (an experimental oral drug)
What this could lead to
If successful, this could point toward a treatment that slows liver damage in people with primary sclerosing cholangitis.
What could go wrong
This is an early Phase 2a trial focused on safety and drug levels, not yet on effectiveness. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

121 people

The number who actually took part.

Started

Jul 2020

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Established clinical diagnosis of large duct PSC based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic cholangiopancreatography (PTC) in the context of cholestatic liver chemistry * Suspected liver fibrosis, as defined by liver stiffness measurement (LSM), assessed by ultrasound-based transient elastography (TE, FibroScan®) OR Enhanced Liver Fibrosis (ELF) Score OR Historical liver biopsy showing fibrosis without cirrhosis (by any scoring system) OR Magnetic resonance elastography (MRE) * Serum ALP concentration within normal limits or \> 1 times the upper limit of normal (ULN) * Participants receiving treatment for IBD are allowed, if on a stable dose from screening and expected to remain stable for the duration of the study * Serum AST and ALT concentration ≤ 5 times the upper limit of normal * If receiving treatment with UDCA, therapy is at a dose of \< 25 mg/kg/day, has been stable for at least 3 months before screening. Exclusion Criteria: * Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically * Known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis * Small duct PSC with no evidence of large duct involvement (evidence of PSC on historical liver histology, with normal bile ducts on cholangiography) * Presence of liver cirrhosis as assessed by liver histology, ultrasound-based liver stiffness measurement, ELF score, MRE, and/or signs and symptoms of hepatic decompensation (including but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy. * Serum ALP concentration \> 10 times the upper limit of normal.

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Conditions

The condition(s) this trial relates to.

Cholangitis, Sclerosing primary sclerosing cholangitis

As listed by the trial registrant

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

Primary sclerosing cholangitis

Contacts and locations

Locations

  • (G.I.R.I) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Amsterdam UMC

    Amsterdam, 1105 AZ, Netherlands

  • Aspen Woods Clinic

    Calgary, Alberta, T3H 0V5, Canada

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030, United States

  • Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia, 23602, United States

  • C.H.U. Hautepierre

    Strasbourg, 67200, France

  • CHU Grenoble Alpes - Hôpital Michallon

    Grenoble, 38043 CEDEX 9, France

  • CHU de Lille service MAD

    Lille, 59037, France

  • California Liver Research Institute

    Pasadena, California, 91105, United States

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94109, United States

  • Centre Hépato-Biliaire - Hôpital Paul-Brousse

    Villejuif, 94800, France

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

    Montreal, Quebec, H2X 0A9, Canada

  • Charité University Medicine Berlin

    Berlin, 13353, Germany

  • Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme

    Brussels, 1070, Belgium

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Erasmus University Medical Center

    Rotterdam, 3015 GD, Netherlands

  • Florida Research Institute

    Lakewood Rch, Florida, 34211, United States

  • Ghent University Hospital

    Ghent, 9000, Belgium

  • Henry Ford Health System

    Novi, Michigan, 48377, United States

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • John Radcliffe Hospital/Oxford University Hospital

    Headington, Oxford, OX3 9DU, United Kingdom

  • King's College Hospital NHS Foundation Trust, Denmark Hill

    London, SE5 9RS, United Kingdom

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Liverpool Hospital: Department of Gastroenterology and Hepatology

    Liverpool, New South Wales, 2170, Australia

  • London Health Sciences Centre-University Hospital

    London, Ontario, N6A 5A5, Canada

  • Massachusetts General Hospital Gastroenterology Liver Center

    Boston, Massachusetts, 02114, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1, Canada

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5, Canada

  • Medical University of Vienna Div. of Gastroenterology and Hepatology

    Vienna, A-1090, Austria

  • Medizinische Universität Graz

    Graz, 8036, Austria

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Saint Antoine Hospital/ Hepatology Department

    Paris, 75012, France

  • Schiff Center of Liver Diseases/University of Miami

    Miami, Florida, 33136, United States

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • St. Vincent's Hospital

    Melbourne, Victoria, 3065, Australia

  • Stanford University School of Medicine

    Redwood City, California, 94063, United States

  • The Alfred

    Melbourne, Victoria, 3004, Australia

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University Hospital Erlangen

    Erlangen, 91054, Germany

  • University Hospital Heidelberg

    Heidelberg, 69120, Germany

  • University Hospitals Birmingham NHS

    Birmingham, B15 2GW, United Kingdom

  • University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine

    Hamburg, 20246, Germany

  • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

    Edmonton, Alberta, T6G 2X8, Canada

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of California, Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Universitätsmedizin Mainz, I. Med. Klinik

    Mainz, 55131, Germany

  • VCU Health Clinical Research Services Unit

    Richmond, Virginia, 23298, United States

  • Vanderbilt Digestive Disease Center

    Nashville, Tennessee, 37232, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Yale School of Medicine

    New Haven, Connecticut, 06511, United States

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