Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis. The primary objective of this study is to evaluate the effect of seladelpar compared to placebo on EFS. EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156.
Study identification
- NCT ID
- NCT06051617
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 402 participants
Conditions and interventions
Conditions
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 7, 2023 (Actual)
- Primary completion
- Aug 2030 (Estimated)
- Completion
- Aug 2030 (Estimated)
- Last update posted
- Oct 6, 2026
2023 – 2030
United States locations
- U.S. sites
- 54
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Recruiting |
| 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 |
| Kaiser Roseville | Roseville | California | 95661 | 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 |
| Kaiser Permanente - South San Francisco Medical Center | South San Francisco | California | 94080 | 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 |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Northwell Health Center for Liver Disease and Transplantation | Manhasset | New York | 11030 | Recruiting |
| NYU Langone Health | New York | New York | 10016 | Recruiting |
| New York-Presbyterian/Weill Cornell Medical Center | New York | New York | 10021 | 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 |
| Medical College of Wisconsin - 8701 Watertown Plan | Milwaukee | Wisconsin | 53226 | 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 163 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 Oct 6, 2026 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06051617 live on ClinicalTrials.gov.