A study testing whether a new weekly shot from National Institute on Alcohol Abuse and Alcoholism (NIAAA), tirzepatide, can improve fatty liver disease.

Who can join
Adults 21 to 100, have metabolic alcohol-associated liver disease, BMI 25+.
What you take
tirzepatide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
How long it lasts
The study runs about 1 months.
What you get
The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
Phase Phase 2Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)Drug tirzepatideClass GLP-1/GIPSites 1 USEnrollment target 120

What this study is for

Primary condition: Metabolic Alcohol-associated Liver Disease. Also studied in: Alcohol Use Disorder.

Full scientific study title: Tirzepatide in MetALD.

Who can join

Age21 to 100SexAnyBMI25 to 40

Adults 21 to 100, have metabolic alcohol-associated liver disease, BMI 25+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.

Full medical eligibility (for you and your doctor)verbatim from the registry

This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.

Key inclusion criteria

  • Age 21 or older
  • Ability to provide written informed consent
  • Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives and an additional barrier method of contraceptive such as condoms; use of an approved IUD or other longacting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s)
  • Males: Agree to abstain or use accepted form of contraception, such as condoms.
  • Diagnosis of AUD as confirmed by MINI

Key exclusion criteria

  • Treatment seeking for alcohol use disorder
  • History of a serious hypersensitivity reaction to GLP-1RA/GIPRA
  • Current/past use of GLP-1RA/GIPRA within the last 3 months
  • Clinically significant and/or unstable cardiovascular disease over the past 12 months
  • History of diabetes mellitus or blood hemoglobin A1c (HbA1c) >= 6.5 % at screening

Where this study is enrolling

This trial has 1 sites across 1 state. Contact a site coordinator directly to start screening.

Maryland1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland
    NIH Clinical Center Office of Patient Recruitment (OPR)800-411-1222ccopr@nih.gov

Timeline

Started enrolling: 2026-06-11. Expected completion: 2026-07-30. Last updated on ClinicalTrials.gov: 2026-06-16.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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