New trial aims to treat both liver damage and alcohol addiction at once

NCT ID NCT07060638

Recruiting now Disease control Sponsor: Samer Gawrieh Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 4 times

Summary

This study tests whether adding alcohol use disorder treatments (acamprosate and counseling) to standard liver therapy improves outcomes for people with severe alcohol-associated hepatitis. It also compares a new drug, F-652, against prednisone for liver treatment. About 216 adults aged 18-70 with severe liver inflammation and heavy alcohol use will participate. The goal is to see if the combined approach reduces death, liver complications, and return to drinking over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: F-652 (IL-22), prednisone, acamprosate, and motivational interviewing
What this could lead to: If successful, this could point toward a combined treatment approach that improves both liver health and alcohol abstinence in people with severe alcohol-associated hepatitis.
What could go wrong: This is an early phase 2 trial with 216 participants, so results may not apply to everyone. The treatments may not improve outcomes or could cause side effects like infections or liver complications.

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcoholic hepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALCOHOL-ASSOCIATED HEPATITIS

Contacts and locations

Locations

Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Indiana University
RECRUITING

Indianapolis, Indiana, 46202, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55902, United States
University of Louisville
RECRUITING

Louisville, Kentucky, 40292, United States
University of Texas Southwestern Medical School
RECRUITING

Dallas, Texas, 15260, United States
Virginia Commonwealth University
RECRUITING

Richmond, Virginia, 23284, United States

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