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

Conditions

• Hepatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Larsucosterol — DRUG
  Larsucosterol intravenous infusion.
• Placebo — DRUG
  Matching-placebo (sterile water for injection) intravenous infusion.

Study Details

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.

Key Dates

First listed

Feb 23, 2026

Start date

Jan 29, 2026

Status verified

Jul 2026

Primary completion

Nov 30, 2027

Completion

Feb 29, 2028

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Larsucosterol 30 mg
  Participants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.
• Placebo Comparator: Placebo
  Participants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.

Primary Outcome Measure

Transplant Free Survival up to Day 90 [ Time Frame: Up to Day 90 ]

Central Contacts

• Varsha Bhatt
  707-230-1712
  [email protected]
• Alycia Olsen
  201-846-8376
  [email protected]

Locations (84)

Find similar trials in Birmingham, AL