Larsucosterol for Alcoholic Hepatitis

Recruiting at 47 trial locations

Overseen By Natalie Pastelak

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bausch Health Americas, Inc.

Must not be taking: Systemic corticosteroids

Disqualifiers: Active infection, Uncontrolled HIV, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jimin Lee, Ph.D

Principal Investigator

Bausch Health Americas, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

1. Able to provide written informed consent (either from participant or participant's legally acceptable representative).

2. Onset of jaundice within 8 weeks before hospital admission.

3. 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intravenous infusion of Larsucosterol or placebo on Day 1

1 day

Follow-up

Participants are monitored for safety and efficacy, with transplant-free survival assessed through Day 90

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Larsucosterol

How Is the Trial Designed?

Group I: Larsucosterol 30 mg Experimental Treatment 1 Intervention

Participants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

Durect

Industry Sponsor

Trials

17

Recruited

2,100+