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New hope for PBC patients: Long-Term safety trial of seladelpar underway

NCT ID NCT03301506

Disease control Sponsor: Gilead Sciences 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing the long-term safety of a drug called seladelpar in people with primary biliary cholangitis (PBC), a chronic liver disease. About 340 adults who have taken seladelpar before will receive either 5 mg or 10 mg daily for several years. Researchers will monitor side effects, liver function, and overall health to see if the drug remains safe over time.

What this could mean

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

Active substance
Seladelpar (also known as MBX-8025, Livdelzi®)
What this could lead to
If successful, this could confirm seladelpar as a safe long-term treatment option for managing primary biliary cholangitis, potentially slowing disease progression.
What could go wrong
This is an open-label study without a placebo group, so results may be less definitive. Side effects are possible, and long-term benefits are not guaranteed.

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

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2017

Expected to finish

Dec 2028

An estimate. End dates often move.

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: 1. Must have given written informed consent (signed and dated) 2. Participated in a PBC study with seladelpar 3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals 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 Exclusion Criteria: Exclusion criteria are only applicable for individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption. 1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar 2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection) 3. AST or ALT above 3 × the upper limit of normal (ULN) 4. Total bilirubin above 2 × ULN 5. MELD score ≥ 12. For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor. 6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN) 7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula) 8. Auto-immune hepatitis 9. Primary sclerosing cholangitis 10. Known history of alpha-1-antitrypsin deficiency 11. Known history of chronic viral hepatitis 12. For females, pregnancy or breast-feeding 13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (\>2 weeks) within 2 months prior to Screening 14. Current use of fibrates or use of fibrates within 3 months prior to Screening 15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening 16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening 17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening 18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening 19. 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 20. Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics) 21. Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis 22. Positive for: 1. Hepatitis B, defined as the presence of hepatitis B surface antigen 2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA) 3. Human immunodeficiency virus (HIV) antibody 23. Active COVID-19 infection during screening 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 cirrhosis

Contacts and locations

Locations

  • AP-HP - Hôpital Saint Antoine

    Paris, 75012, France

  • Ankara Bilkent City Hospital

    Çankaya, 06800, Turkey (Türkiye)

  • Arkansas Diagnostic Center

    Little Rock, Arkansas, 72205, United States

  • Asan Medical Center

    Songpa-Gu, 05505, South Korea

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2

    Palermo, 90127, Italy

  • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

    Modena, 41126, Italy

  • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

    London, E1 1BB, United Kingdom

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center - 330 Brookline Ave

    Boston, Massachusetts, 02215, United States

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Topkapı, 34093, Turkey (Türkiye)

  • Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226, United States

  • CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278

    Balvanera, C1056ABJ, Argentina

  • California Liver Research Institute

    Pasadena, California, 91105, United States

  • California Pacific Medical Center

    San Francisco, California, 94115, United States

  • Carmel Medical Center

    Haifa, 34462, Israel

  • Centro Clinico Mediterraneo

    La Serena, 1720506, Chile

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Christchurch Hospital

    Christchurch, 4710, New Zealand

  • Consultorio Medico - Distrito Federal

    Roma Norte, 06700, Mexico

  • Consultorio de la Doctora Maria Sarai Gonzalez Huezo

    Metepec, 52120, Mexico

  • Covenant Research Fort Myers

    Fort Myers, Florida, 33606, United States

  • Covenant Research, LLC

    Sarasota, Florida, 33912, United States

  • DIM Clínica Privada

    El Palomar, 1684, Argentina

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Digestive Healthcare of Georgia PC

    Atlanta, Georgia, 30309, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Dunedin Hospital

    Dunedin, 9012, New Zealand

  • East Jefferson General Hospital

    New Orleans, Louisiana, 70112, United States

  • Ege Universitesi Tip Fakultesi Hastanesi

    Bornova, 35100, Turkey (Türkiye)

  • Fakultni nemocnice Ostrava

    Ostrava, 708 00, Czechia

  • Florida Digestive Health Specialist

    Lakewood Rch, Florida, 34211, United States

  • Fondazione IRCCS San Gerardo dei Tintori

    Rozzano, 20089, Italy

  • Fundeni Clinical Institute

    Bucharest, 22328, Romania

  • Galen Medical Group

    Chattanooga, Tennessee, 37404, United States

  • Gastro One-8110 Walnut Run Rd

    Cordova, Tennessee, 38018, United States

  • Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134

    Kiel, 24146, Germany

  • Gastroenterologische Gemeinschaftspraxis Herne

    Herne, 44623, Germany

  • Gazi University Faculty of Medicine

    Ankara, 6590, Turkey (Türkiye)

  • Hadassah Medical Center- Ein Kerem - PPDS

    Jerusalem, 91120, Israel

  • Henry Ford Health System

    Novi, Michigan, 48377, United States

  • Hospices Civils de Lyon - Hôpital de La Croix Rousse

    Lyon, 69004, France

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Italiano de Buenos Aires

    Buenos Aires, 1181, Argentina

  • Hospital Italiano de La Plata

    La Plata, B1902AWL, Argentina

  • Hospital Universitario 12 de Octubre

    Madrid, 28026, Spain

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitario La Paz - PPDS

    Horcajo de la Sierra, 28755, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hull Royal Infirmary

    Hull, HU3 2JZ, United Kingdom

  • ID Clinic Arkadiusz Pisula

    Mysłowice, 41-400, Poland

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Klinikum Wels-Grieskirchen GmbH - Standort Wels

    Wels, 4710, Austria

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Liver Institute Northwest, PLLC

    Seattle, Washington, 98195, United States

  • Liver Institute at Methodist Dallas

    Dallas, Texas, 75203, United States

  • MNGI Digestive Health PA-Plymouth

    Minneapolis, Minnesota, 55413, United States

  • Marmara University Pendik Training and Research Hospital

    Maltepe, 34840, Turkey (Türkiye)

  • Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia, 23602, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mercy Medical Center (Baltimore)

    Baltimore, Maryland, 21202, United States

  • NYU Langone Medical Center

    New York, New York, 10021, United States

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas, 78229, United States

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY, United Kingdom

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH, United Kingdom

  • Queen's Medical Centre

    Nottingham, NG7 2UH, United Kingdom

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov

    Saint Petersburg, 197110, Russia

  • Saint Louis University

    St Louis, Missouri, 63104, United States

  • Semmelweis Egyetem

    Budapest, 1082, Hungary

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400, Hungary

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 14584, South Korea

  • Southern Therapy and Advanced Research LLC

    Jackson, Mississippi, 39157, United States

  • Stanford University School of Medicine

    Palo Alto, California, 94305, United States

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    Tel Aviv, 6423906, Israel

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Chaim Sheba Medical Center - PPDS

    Tel Aviv, 5262100, Israel

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE4 6BE, United Kingdom

  • The Texas Liver Institute - 607 Camden St

    San Antonio, Texas, 78215 1619, United States

  • Toronto General Hospital

    Toronto, M5G 2C4, Canada

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitatsklinkum Erlangen-Ulmenweg 18

    Erlangen, 91054, Germany

  • University General Hospital of Larissa

    Larissa, 411 10, Greece

  • University of Calgary Medicine

    Calgary, T2N 4Z6, Canada

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Chicago Hospitals

    Chicago, Illinois, 60637, United States

  • University of Colorado - Denver - PPDS

    Aurora, Colorado, 80045, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center - PPDS

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 39090, United States

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsspital Zürich

    Zurich, 8091, Switzerland

  • Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

    Katowice, 40-752, Poland

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

  • Weill Cornell Medical College

    New York, New York, 10021, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

  • ifi-Institute for Interdisciplinary Medicine

    Hamburg, 20099, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.