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

Phase 3

Recruiting

• Conditions: Primary Biliary Cholangitis
• Interventions: Drug: Seladelpar; Drug: Placebo

• Registration Number: NCT06051617
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2023-09-07
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2030-08
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 318

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) ≥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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seladelpar	Seladelpar	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Event Free Survival (EFS)	36 months	EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events: 1. Death by any cause; 2. Liver transplantation; 3. MELD score ≥15; 4. Ascites requiring treatment; 5. Hospitalization for any of the following: 1. Esophageal or gastric variceal bleeding; 2. Hepatic encephalopathy; 3. Spontaneous bacterial peritonitis

Secondary Outcome Measures

Name	Time	Method
Time to Event Free Survival (EFS)	36 months	1. MELD score ≥15; 2. Ascites requiring treatment
Overall survival	36 months	Time from start of treatment to death from any cause.
Liver transplant-free survival	36 months	Time from start of treatment to the first occurrence of liver-related death or liver transplantation.
Time to hospitalization	36 months	Time from start of treatment to the first occurrence of hospitalization for qualifying PBC clinical events

Trial Locations

Locations (58)

OM Research LLC; 🇺🇸 Lancaster, California, United States

SCPMG/Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

Cedar Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

California Liver Research Institute; 🇺🇸 Pasadena, California, United States

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States

California Pacific Medical Center - Sutter Pacific Medical Foundation; 🇺🇸 San Francisco, California, United States

Connie Frank Transplant Center at UCSF; 🇺🇸 San Francisco, California, United States

Covenant Metabolic Specialists, LLC; 🇺🇸 Sarasota, Florida, United States

Schiff Center for Liver Diseases/University of Miami; 🇺🇸 Miami, Florida, United States

Florida Research Institute; 🇺🇸 Tampa, Florida, United States

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