Recruiting

Testing a new medication to help people with alcohol-related liver disease

Plain-English translation of NCT05018481 on ClinicalTrials.gov ↗ · Source last updated November 2025 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new medication called HA35 to see if it can help people with alcoholic hepatitis—a serious liver condition caused by heavy alcohol use. Researchers want to understand how HA35 works in the body and whether it helps preserve muscle strength and improve liver health when combined with standard treatment.

Alcoholic hepatitis can damage both the liver and muscles, making recovery difficult. This medication is being studied to see if it offers additional benefits beyond standard care, potentially helping people heal better and regain strength.

Do you qualify?

You likely qualify if…

you have been diagnosed with alcoholic hepatitis (confirmed by blood tests showing specific liver enzyme patterns and bilirubin levels, or by a liver biopsy)
you have consumed alcohol at high levels (over 60 grams daily for men or 40 grams daily for women) for at least six months
your liver disease is moderate (measured by a MELD score below 21, meaning it's not yet at the most severe stage)
you are able and willing to provide informed consent to participate

You likely don't qualify if…

you are pregnant or breastfeeding
you have had gastrointestinal bleeding in the past two weeks
you have an active infection or signs of severe liver failure (encephalopathy, kidney failure, or very abnormal blood clotting)
you have or are being treated for other serious conditions like cancer, end-stage organ disease, or myopathy (muscle disease)
you are currently taking medications that significantly affect muscle metabolism or blood clotting

What participation looks like

You would visit the clinic at the start and again after three months. At each visit, you'll have a physical exam, blood tests, muscle strength tests, and a small muscle biopsy (a tiny tissue sample taken from your thigh). You'll also complete questionnaires, provide stool and urine samples, and take either the study medication or a placebo once daily with breakfast for 90 days. Throughout the trial, you'll continue receiving your standard medical care for alcoholic hepatitis.

AI-generated summary from trial data · Jun 9, 2026 · Not medical advice

Trial locations(1 site)

United States

Cleveland Clinic, Cleveland, Ohio