Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

NCT03301506 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: CB8025-31731-RE2020-005198-292024-511753-22-00
• Study Type: interventional
• Target: 340
• Locations: 24 countries
• Sites: 106

Brief Summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Conditions

Primary Biliary Cirrhosis

Keywords

PBC; Primary Biliary Cholangitis (PBC)

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results

  Through study completion, up to 60 Months

Secondary Outcomes (17)

• Death

  60 Months

• Liver transplantation

  60 Months

• Change in MELD

  60 Months

• Ascites

  60 Months

• Hospitalization for variceal bleeding

  60 Months

Study Arms (2)

Seladelpar 5 mg Capsules

EXPERIMENTAL

Drug: Seladelpar 5 mg Capsule

Seladelpar 10 mg Capsule

EXPERIMENTAL

Drug: Seladelpar 10 mg Capsule

Interventions

Seladelpar 10 mg Capsule DRUG

Participants will be assigned to a treatment group unless there are tolerability issues.

Also known as: MBX-8025, Livdelzi®

Seladelpar 10 mg Capsule

Seladelpar 5 mg Capsule DRUG

Participants will be assigned to a treatment group if tolerability issues noted in the previous study.

Also known as: MBX-8025, Livdelzi®

Seladelpar 5 mg Capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have given written informed consent (signed and dated)
• Participated in a PBC study with seladelpar
• 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

You may not qualify if:

• Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
• 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)
• AST or ALT above 3 × the upper limit of normal (ULN)
• Total bilirubin above 2 × ULN
• 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.
• 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)
• eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
• Auto-immune hepatitis
• Primary sclerosing cholangitis
• Known history of alpha-1-antitrypsin deficiency
• Known history of chronic viral hepatitis
• For females, pregnancy or breast-feeding
• Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (\>2 weeks) within 2 months prior to Screening
• Current use of fibrates or use of fibrates within 3 months prior to Screening
• Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (109)

Arkansas Diagnostic Center

Little Rock, Arkansas, 72205, United States

Location

Stanford University School of Medicine

Palo Alto, California, 94305, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Colorado - Denver - PPDS

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Covenant Research Fort Myers

Fort Myers, Florida, 33606, United States

Location

Florida Digestive Health Specialist

Lakewood Rch, Florida, 34211, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Covenant Research, LLC

Sarasota, Florida, 33912, United States

Location

Digestive Healthcare of Georgia PC

Atlanta, Georgia, 30309, United States

Location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

East Jefferson General Hospital

New Orleans, Louisiana, 70112, United States

Location

Mercy Medical Center (Baltimore)

Baltimore, Maryland, 21202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center - 330 Brookline Ave

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

MNGI Digestive Health PA-Plymouth

Minneapolis, Minnesota, 55413, United States

Location

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, 39157, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

NYU Langone Medical Center

New York, New York, 10021, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Rochester Medical Center - PPDS

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania, 18017, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Galen Medical Group

Chattanooga, Tennessee, 37404, United States

Location

Gastro One-8110 Walnut Run Rd

Cordova, Tennessee, 38018, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 39090, United States

Location

Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Texas Liver Institute - 607 Camden St

San Antonio, Texas, 78215 1619, United States

Location

Pinnacle Clinical Research, PLLC

San Antonio, Texas, 78229, United States

Location

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

Newport News, Virginia, 23602, United States

Location

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

Richmond, Virginia, 23226, United States

Location

Liver Institute Northwest, PLLC

Seattle, Washington, 98195, United States

Location

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

Balvanera, C1056ABJ, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, 1181, Argentina

Location

DIM Clínica Privada

El Palomar, 1684, Argentina

Location

Hospital Italiano de La Plata

La Plata, B1902AWL, Argentina

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Klinikum Wels-Grieskirchen GmbH - Standort Wels

Wels, 4710, Austria

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

University of Calgary Medicine

Calgary, T2N 4Z6, Canada

Location

Toronto General Hospital

Toronto, M5G 2C4, Canada

Location

Centro Clinico Mediterraneo

La Serena, 1720506, Chile

Location

Fakultni nemocnice Ostrava

Ostrava, 708 00, Czechia

Location

Hospices Civils de Lyon - Hôpital de La Croix Rousse

Lyon, 69004, France

Location

AP-HP - Hôpital Saint Antoine

Paris, 75012, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitatsklinkum Erlangen-Ulmenweg 18

Erlangen, 91054, Germany

Location

ifi-Institute for Interdisciplinary Medicine

Hamburg, 20099, Germany

Location

Gastroenterologische Gemeinschaftspraxis Herne

Herne, 44623, Germany

Location

Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134

Kiel, 24146, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

University General Hospital of Larissa

Larissa, 411 10, Greece

Location

Semmelweis Egyetem

Budapest, 1082, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

Location

Carmel Medical Center

Haifa, 34462, Israel

Location

Hadassah Medical Center- Ein Kerem - PPDS

Jerusalem, 91120, Israel

Location

The Chaim Sheba Medical Center - PPDS

Tel Aviv, 5262100, Israel

Location

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Tel Aviv, 6423906, Israel

Location

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

Modena, 41126, Italy

Location

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

Palermo, 90127, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori

Rozzano, 20089, Italy

Location

Consultorio de la Doctora Maria Sarai Gonzalez Huezo

Metepec, 52120, Mexico

Location

Consultorio Medico - Distrito Federal

Roma Norte, 06700, Mexico

Location

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands

Location

Christchurch Hospital

Christchurch, 4710, New Zealand

Location

Dunedin Hospital

Dunedin, 9012, New Zealand

Location

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

Katowice, 40-752, Poland

Location

ID Clinic Arkadiusz Pisula

Mysłowice, 41-400, Poland

Location

Fundeni Clinical Institute

Bucharest, 22328, Romania

Location

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

Saint Petersburg, 197110, Russia

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 14584, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Songpa-Gu, 05505, South Korea

Location

Hospital Universitario Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitario La Paz - PPDS

Horcajo de la Sierra, 28755, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28026, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Gazi University Faculty of Medicine

Ankara, 6590, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi

Bornova, 35100, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital

Çankaya, 06800, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Maltepe, 34840, Turkey (Türkiye)

Location

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Topkapı, 34093, Turkey (Türkiye)

Location

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

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

London, E1 1BB, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Queen's Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

Related Publications (2)

• Levy C, Trivedi PJ, Kowdley KV, Gordon SC, Bowlus CL, Londono MC, Hirschfield GM, Gulamhusein A, Lawitz EJ, Vierling JM, Mayo MJ, Jacobson IM, Kremer AE, Corpechot C, Jones D, Buggisch P, Zhuo S, Proehl S, Heusner C, McWherter CA, Crittenden DB; ASSURE Investigators. Long-Term Efficacy and Safety of Selective PPARdelta Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results. Am J Gastroenterol. 2025 Jun 24. doi: 10.14309/ajg.0000000000003603. Online ahead of print.

  PMID: 40553148 DERIVED

• Mayo MJ, Vierling JM, Bowlus CL, Levy C, Hirschfield GM, Neff GW, Galambos MR, Gordon SC, Borg BB, Harrison SA, Thuluvath PJ, Goel A, Shiffman ML, Swain MG, Jones DEJ, Trivedi P, Kremer AE, Aspinall RJ, Sheridan DA, Dorffel Y, Yang K, Choi YJ, McWherter CA. Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis. Aliment Pharmacol Ther. 2024 Jan;59(2):186-200. doi: 10.1111/apt.17755. Epub 2023 Oct 30.

  PMID: 37904314 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

seladelpar; (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 4, 2017
• Study Start: December 12, 2017
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1); ME (2); CL (1); RO (1); IT (3); AR (4); HU (2); NL (1); PL (2); KR (7); TU (5); FR (2); CA (2); AU (1); CZ (1); NZ (2); US (40); GR (1); CH (1); GB (8); IL (4); ES (7); BE (2); DE (6)