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Promising new treatment for rare liver disease shows potential in Late-Stage trial

NCT ID NCT06060665

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a drug called seladelpar in 96 adults with primary biliary cholangitis (PBC), a rare liver disease. Participants had not responded well or could not tolerate the standard treatment. The goal was to see if seladelpar could lower a key liver enzyme (alkaline phosphatase) to normal levels over 52 weeks. This is a disease-control study, as PBC typically requires ongoing management.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

96 people

The number who actually took part.

Started

Sep 2023

Finished

May 2026

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.

Key Inclusion Criteria: Individuals must meet the following criteria to be eligible for study participation: 1. Male or female with a diagnosis of primary biliary cholangitis (PBC) based on history. 2. Ursodeoxycholic acid (UDCA) for the 12 months prior to screening (with stable dose for \> 3 months prior to screening) OR intolerant to UDCA (last dose of UDCA \> 3 months prior to screening). 3. ALP \> 1× ULN and \< 1.67× ULN. 4. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male participants who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose. Key Exclusion Criteria: 1. Previous exposure to seladelpar (MBX-8025). 2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study (eg, cancer) or confound its results. 3. Advanced PBC as defined by the Rotterdam criteria. 4. Laboratory parameters measured by the Central Laboratory at screening. 5. Clinically important hepatic decompensation. 6. Other chronic liver diseases. 7. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening. 8. Clinically important alcohol consumption, defined as more than 2 drink units per day in women and 3 drink units per day in men, or inability to quantify alcohol intake reliably. 9. History of malignancy diagnosed or treated, active or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening. 10. History of drug abuse that would compromise the quality of the clinical study. 11. Treatment with obeticholic acid or fibrates 6 weeks prior to screening. 12. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids within 2 months prior to screening. 13. Initiation or dose adjustment of anti-pruritic drugs indicated for the treatment of pruritus within 1 month prior to screening. 14. Immunosuppressant therapies within 6 months prior to screening. 15. Other medications that affect liver or gastrointestinal functions, as well as the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case by-case basis. 16. Treatment with any other investigational therapy or device within 30 days or within halflives, whichever is longer, prior to screening. 17. Pregnancy or plans to become pregnant, or breastfeeding. 18. Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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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 Foundation

    Vancouver, V6Z 2K5, Canada

  • American Research Corporation - San Antonio, TX

    Austin, Texas, 78757, United States

  • Baylor College of Medicine - Baylor Clinic

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Bon Secours Liver Institute of Hampton Roads

    Richmond, Virginia, 23226, United States

  • California Liver Research Institute

    Pasadena, California, 91105, United States

  • California Pacific Medical Center

    San Francisco, California, 94115, United States

  • Centre de Recherche du Centre Hospitallier de I'Universite de Montreal (CRCHUM)

    Montreal, H2X3J4, Canada

  • Covenant Metabolic Specialists, LLC

    Sarasota, Florida, 33912, United States

  • Covenant Metabolic Specialists, LLC

    Tampa, Florida, 33606, United States

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309, United States

  • Florida Research Institute

    Lakewood Rch, Florida, 34211, United States

  • Galen Hepatology

    Hixson, Tennessee, 37343, United States

  • Gastro Health Research

    Miami, Florida, 33176, United States

  • Gastro Health Research

    Liberty Township, Ohio, 45044, United States

  • Gastrointestinal Associates of Northeast Tennessee, P.C.

    Johnson City, Tennessee, 37604, United States

  • Henry Ford Health System

    Novi, Michigan, 48377, United States

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • Liver Associates of Texas, P.A.

    Houston, Texas, 77030, United States

  • Liver Center of Texas

    Dallas, Texas, 75234, United States

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mercy Medical Center - Baltimore, Maryland

    Baltimore, Maryland, 21202, United States

  • New York University (NYU) Langone Medical Center

    New York, New York, 10016, United States

  • New-York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215, United States

  • Northwell Health Center for Liver Disease and Transplantation

    Manhasset, New York, 11030, United States

  • Northwestern Medicine Clinical Research Unit (CRU)

    Chicago, Illinois, 60611, United States

  • OGI - Gastro One

    Cordova, Tennessee, 38018, United States

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Soma Clinical Trials, LLC

    Denison, Texas, 75020, United States

  • South Denver Gastroenterology

    Englewood, Colorado, 80113, United States

  • Stanford University

    Seattle, Washington, 98195, United States

  • The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health

    Chandler, Arizona, 85224, United States

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112, United States

  • UPMC Center for Liver Health

    Pittsburgh, Pennsylvania, 15213, United States

  • University of California (UC) Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Colorado Denver - School of Medicine - Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Miami - Schiff Center for Liver Diseases

    Miami, Florida, 33136, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Rochester Medical Center - Strong Memorial Hospital

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Velocity Clinical Research - Seattle

    Seattle, Washington, 98105, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

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