Evaluation of Larsucosterol Treatment for Adults with Severe Alcohol-Associated Hepatitis Using Intravenous Infusion

What this Trial Is About

Researchers are evaluating the safety and effectiveness of larsucosterol in adults with severe alcohol-associated hepatitis AH, specifically those with a Maddrey Discriminant Function score of 32 or higher and Model for End-stage Liver Disease scores between 21 and 30. The study focuses on transplant-free survival through Day 90 and is sponsored by Bausch Health Americas, Inc. It is a Phase 3, randomized, double-blind trial comparing larsucosterol to placebo. Participants receive a single intravenous infusion of either 30 mg larsucosterol or a matching placebo on Day 1. The trial uses a parallel design with two groups one receiving the experimental drug and the other receiving placebo. The study treatment is administered within 9 days of hospital admission, with specific eligibility criteria to ensure appropriate participant selection. During the study, participants are monitored for transplant-free survival up to Day 90, along with overall survival, time to death, hospital days, ICU use, and changes in liver function scores through Day 180. Safety and efficacy outcomes include measurements such as bilirubin levels and Model for End-stage Liver Disease scores. Participants are followed closely with assessments throughout the study duration, which extends through February 2028.

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