Clinical Trial

Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.
Protocol Amendment History 6 changes
notable Trial sites expanded: 48 -> 84 locations 2026-07-23
notable Primary completion pushed: 2027-06-29 -> 2027-11 2026-05-08
minor Completion pushed: 2027-07-29 -> 2028-02 2026-05-08
notable Trial sites expanded: 1 -> 48 locations 2026-04-04
notable Primary completion moved earlier: 2028-06-29 -> 2027-06-29 2026-04-04
minor Completion moved earlier: 2028-07-29 -> 2027-07-29 2026-04-04
Trial Details
NCT Number NCT07428538
Lead Sponsor Bausch Health Americas, Inc.
Collaborators: Durect
Conditions Hepatitis
Enrollment 350 participants
Start Date 2026-01-29
Primary Completion 2027-11 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-22