drugset / Trial / NCT06051617

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

NCT06051617 ↗

Phase 3 Recruiting 402 enrolled Gilead Sciences
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2023-09-07
Primary completion
2030-08
Completion
2030-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Seladelpar Small molecule 5 mg Oral
Subject Seladelpar Small molecule 10 mg Oral