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Evaluating Seladelpar for Primary Biliary Cholangitis with Cirrhosis

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

PHASE3 · Gilead Sciences · NCT06051617

This study is testing if a new medication called Seladelpar can help adults with Primary Biliary Cholangitis and cirrhosis feel better and improve their liver health.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment318 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences (industry)
Locations196 sites (Phoenix, Arizona and 195 other locations)
Trial IDNCT06051617 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Seladelpar in improving clinical outcomes for patients diagnosed with Primary Biliary Cholangitis (PBC) who also have compensated cirrhosis. Participants will receive either Seladelpar or a placebo, and their health will be monitored throughout the study. The trial aims to determine if Seladelpar can provide significant benefits in managing this chronic liver disease. Eligible participants must be at least 18 years old and have a confirmed diagnosis of PBC with evidence of cirrhosis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Primary Biliary Cholangitis and evidence of compensated cirrhosis.

Not a fit: Patients who have previously been treated with Seladelpar or have other significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Primary Biliary Cholangitis and enhance the quality of life for affected patients.

How similar studies have performed: Other studies have shown promise in treating Primary Biliary Cholangitis, but the specific use of Seladelpar in this context is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 195 other locations

+146 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Biliary Cholangitis, PBC

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.