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.
Able to provide written informed consent (either from participant or participant's legally acceptable representative).
Onset of jaundice within 8 weeks before hospital admission.
Average daily consumption of greater than (>) 40 (females) or >60 (males) grams alcohol for 6 months or longer, with less than (<) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator.
Serum total bilirubin >3.0 milligrams per deciliter (mg/dL) (required at randomization)
Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening.
Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.
Bausch Health Americas, Inc.
Lead sponsor
Durect
Collaborator