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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06051617

Public ClinicalTrials.gov record NCT06051617. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 8, 2026, 3:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Study identification

NCT ID
NCT06051617
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
318 participants

Conditions and interventions

Interventions

  • Placebo Drug
  • Seladelpar Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 6, 2023
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030
Last update posted
Apr 29, 2026

2023 – 2030

United States locations

U.S. sites
48
U.S. states
21
U.S. cities
39
Facility City State ZIP Site status
St. Joseph's Hospital and Medical Center - 350 W. Thomas Phoenix Arizona 85013 Recruiting
OM Research LLC Lancaster California 93534 Recruiting
SCPMG/Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027 Recruiting
Cedar Sinai Medical Center Los Angeles California 90048 Recruiting
California Liver Research Institute Pasadena California 91105 Recruiting
Stanford University Redwood City California 94063 Recruiting
University of California, Davis Medical Center Sacramento California 95817 Recruiting
California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco California 94109 Recruiting
Connie Frank Transplant Center at UCSF San Francisco California 94143 Recruiting
Covenant Metabolic Specialists, LLC Fort Myers Florida 33912 Recruiting
Schiff Center for Liver Diseases/University of Miami Miami Florida 33136 Recruiting
Covenant Metabolic Specialists, LLC Sarasota Florida 33912 Recruiting
Florida Research Institute Tampa Florida 34211 Recruiting
Piedmont Atlanta Hospital / Piedmont Transplant Institute Atlanta Georgia 30309 Recruiting
Northwestern University Chicago Illinois 60611 Recruiting
University of Chicago Medical Center Chicago Illinois 60637 Recruiting
University Of Iowa Hospitals And Clinics Iowa City Iowa 52242 Recruiting
University of Louisville, Clinical Trials Unit Louisville Kentucky 40202 Recruiting
Ochsner Clinic Foundation Jefferson Louisiana 70121 Recruiting
University Health System - East Jefferson General Hospital Campus New Orleans Louisiana 70112 Recruiting
Mercy Medical Center Baltimore Maryland 21202 Recruiting
Walter Reed National Military Bethesda Maryland 20889 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Recruiting
Henry Ford Medical Center - Columbus Detroit Michigan 48202 Recruiting
University of Rochester Medical Center - Strong Memorial Hospital Rochester Minnesota 14642 Recruiting
Northwell Health Center for Liver Disease and Transplantation Manhasset New York 11030 Recruiting
NYU Langone Health New York New York 10016 Recruiting
Mount Sinai New York New York 10029 Recruiting
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 Recruiting
University Hosptials Cleveland Medical Center Cleveland Ohio 44106 Recruiting
The Cleveland Clinic Foundation Cleveland Ohio 44195 Recruiting
The Ohio State University Medical Center Columbus Ohio 43210 Recruiting
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania 17033 Recruiting
University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia Pennsylvania 19104 Recruiting
Thomas Jefferson University Philadelphia Pennsylvania 19107 Recruiting
UPMC Center for Liver Diseases Pittsburgh Pennsylvania 15213 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
Gastro One Cordova Tennessee 38018 Recruiting
The Liver Institute at Methodist Dallas Medical Center Dallas Texas 75203 Recruiting
University of Texas Southwestern Medical Center, Professional Office Building One Dallas Texas 75390 Recruiting
Soma Clinical Trials Denison Texas 75020 Recruiting
American Research Corporation San Antonio Texas 78215 Recruiting
Pinnacle Clinical Research, PLLC San Antonio Texas 78229 Recruiting
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax Fairfax Virginia 22031 Recruiting
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads Newport News Virginia 23602 Recruiting
VCU Health Clinical Research Services Unit (CRSU) Richmond Virginia 23298 Recruiting
Liver Institute Northwest Seattle Washington 98105 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 148 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06051617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 29, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06051617 live on ClinicalTrials.gov.

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