RecruitingPhase 2NCT07046819

Tirzepatide in MetALD

A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Phase 2 Study of Efficacy and Safety of Tirzepatide in Individuals With Alcohol Use Disorder and Metabolic Alcohol-associated Liver Disease


Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Enrollment

120 participants

Start Date

Jun 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Background: People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake. Objective: To test Tirzepatide in people with AUD and MetALD. Eligibility: People aged 21 years and older with AUD and MetALD. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a Fibroscan: This test uses ultrasound to measure how stiff the liver is. They will answer questions about their alcohol drinking, eating habits, and mental health. Participants may opt to have imaging scans of their brain and liver. These tests will be repeated in a baseline visit. This visit will take up to 6 hours. Tirzepatide is injected under the skin once a week for 12 weeks. Participants will visit the clinic to receive each injection. Some participants will get a placebo. A placebo is given just like a Tirzepatide injection but contains no medicine. The physical exam and other tests will be repeated during clinic visits. The Fibroscan will be repeated every 2 weeks during the study. Each weekly visit will take up to 3 hours. All tests will be repeated on the last visit. These tests will include the imaging scans and Fibroscan. Participants will learn about treatment options for AUD; they will be given recommendations on ways to reduce alcohol intake. This visit will take up to 6 hours.


Eligibility

Min Age: 21 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a drug called Tirzepatide for people with alcohol use disorder and metabolic alcohol-associated liver disease. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.

OTHERPlacebo

A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT07046819


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