Recruiting

Phase 3

SeladelparSeladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Sponsor:

Gilead Sciences

Code:

NCT06051617

Conditions

Primary Biliary Cholangitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Seladelpar

Placebo

Study Details

Brief summary:

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Conditions

Primary Biliary Cholangitis

Study ID

NCT06051617

Start date

Sep 7, 2023

Status verified date

Aug, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Individuals must meet the following criteria to be eligible for study participation:

1. Must be at least 18 years old.
2. Must have a confirmed prior diagnosis of PBC
3. Evidence of cirrhosis
4. CP Score A or B
5. 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 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
6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

Exclusion Criteria:

Individuals must not meet any of the following criteria to be eligible for study participation:

1. Prior exposure to seladelpar
2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
4. Decompensated cirrhosis
5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
6. Hospitalization for liver-related complication within 12 weeks of Screening
7. Laboratory parameters at Screening:

1. Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN
4. Platelet count ≤50×10\^3/µL
5. Albumin ≤2.8 g/dL
6. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m\^2
7. MELD score >12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
8. Serum alpha-fetoprotein (AFP) >20 ng/mL
9. INR >1.7
8. CP-C cirrhosis
9. History or presence of other concomitant liver diseases

Study Design

Enrollment

318 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Seladelpar

placebo comparator: Placebo

Interventions

Seladelpar

Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or
Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis.

Placebo

One capsule daily for up to 36 months.

Primary outcome measure

Event Free Survival (EFS) [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

St. Joseph's Hospital and Medical Center - 350 W. Thomas

Recruiting

Phoenix, Arizona, United States, 85013

OM Research LLC

Recruiting

Lancaster, California, United States, 93534

SCPMG/Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Cedar Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

California Liver Research Institute

Recruiting

Pasadena, California, United States, 91105

Stanford University

Recruiting

Redwood City, California, United States, 94063

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

California Pacific Medical Center - Sutter Pacific Medical Foundation

Recruiting

San Francisco, California, United States, 94109

Connie Frank Transplant Center at UCSF

Recruiting

San Francisco, California, United States, 94143

Kaiser Permanente - South San Francisco Medical Center

Recruiting

South San Francisco, California, United States, 94080

Covenant Metabolic Specialists, LLC

Recruiting

Fort Myers, Florida, United States, 33912

Schiff Center for Liver Diseases/University of Miami

Recruiting

Miami, Florida, United States, 33136

Covenant Metabolic Specialists, LLC

Recruiting

Sarasota, Florida, United States, 33912

Florida Research Institute

Recruiting

Tampa, Florida, United States, 34211

Piedmont Atlanta Hospital / Piedmont Transplant Institute

Recruiting

Atlanta, Georgia, United States, 30309

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

University Of Iowa Hospitals And Clinics

Recruiting

Iowa City, Iowa, United States, 52242

University of Louisville, Clinical Trials Unit

Recruiting

Louisville, Kentucky, United States, 40202

Ochsner Clinic Foundation

Recruiting

Jefferson, Louisiana, United States, 70121

University Health System - East Jefferson General Hospital Campus

Recruiting

New Orleans, Louisiana, United States, 70112

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Walter Reed National Military

Recruiting

Bethesda, Maryland, United States, 20889

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Henry Ford Medical Center - Columbus

Recruiting

Detroit, Michigan, United States, 48202

University of Rochester Medical Center - Strong Memorial Hospital

Recruiting

Rochester, Minnesota, United States, 14642

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Northwell Health Center for Liver Disease and Transplantation

Recruiting

Manhasset, New York, United States, 11030

NYU Langone Health

Recruiting

New York, New York, United States, 10016

New York-Presbyterian/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021

Mount Sinai

Recruiting

New York, New York, United States, 10029

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

University Hosptials Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

UPMC Center for Liver Diseases

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Gastro One

Recruiting

Cordova, Tennessee, United States, 38018

The Liver Institute at Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

University of Texas Southwestern Medical Center, Professional Office Building One

Recruiting

Dallas, Texas, United States, 75390

Soma Clinical Trials

Recruiting

Denison, Texas, United States, 75020

American Research Corporation

Recruiting

San Antonio, Texas, United States, 78215

Pinnacle Clinical Research, PLLC

Recruiting

San Antonio, Texas, United States, 78229

MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax

Recruiting

Fairfax, Virginia, United States, 22031

Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads

Recruiting

Newport News, Virginia, United States, 23602

VCU Health Clinical Research Services Unit (CRSU)

Recruiting

Richmond, Virginia, United States, 23298

Liver Institute Northwest

Recruiting

Seattle, Washington, United States, 98105

University of Calgary

Recruiting

Calgary, Canada, T2N 4Z6

University of Alberta

Recruiting

Edmonton, Canada, T6G 2B7

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Canada, H2L 4M1

Ottawa Hospital

Recruiting

Ottawa, Canada, K1H 8L6

Diex Recherche - Québec - PPDS

Recruiting

Québec, Canada, G1V 4T3

Toronto General Hospital

Recruiting

Toronto, Canada, M5G 2C4

GI Research Institute Foundation

Recruiting

Vancouver, Canada, V6G 2Z6

More Information

Sponsor

Gilead Sciences

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

Primary Biliary Cholangitis (PBC)
PBC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-08-11.