Tirzepatide in MetALD

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Metabolic Alcohol-associated Liver Disease, Alcohol Use Disorder

In brief

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.

Key facts

Study ID: NCT07046819
Run by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
People needed: 120
Starts: 2026-06-11
Expected to finish: 2026-07-30
Last updated by the study team: 2026-07-22

Who can join

Age: 21 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

An individual who meets any of the following criteria will be excluded from participation in this study:
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
Any underlying clinically significant and/or unstable acute or chronic liver disease unrelated to alcohol use at screening, history of cirrhosis, esophageal varices
Subjects with platelets count of less than 110,000/ mm\^3
Alanine aminotransferase or aspartate aminotransferase exceeding 5 times the upper limit of normal levels at screening
Bilirubin 2x UNL or Creatinine > 2 mg/dL at screening
Patients with coagulopathy defined as INR >1.5, prothrombin time prolonged by > 3s, and/or platelets <75,000 / mm\^3 at screening
Positive HIV test or positive Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV) at screening
Chronic renal failure as estimated by glomerular filtration rate (GFR) < 60mL/min/1.73 m\^2 at screening
History of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
History of previous bariatric surgery or transplant surgery
Patients with significant hematologic abnormalities, as defined by hemoglobin < 8g/dL and/or white blood count <1500 cells/microL
Current or prior history of any clinically significant disease, including, seizure disorder, epilepsy, alcohol related seizures within 12 months of screening, uncontrolled endocrine disease, hemorrhagic stroke, cancer within the past 5 years or any other significant abnormality identified at the time of screening that, in the judgment of the investigator or study clinician, would preclude safe completion of the study
Use of any medications that interfere with tirzepatide
Use of the following medications with glucose lowering properties in the last 30 days: GLP-1RA, GLP-1RA/GIPRA, insulin, metformin, sulfonylurea, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors
Use of the following medications: Any medication that requires intramuscular administration injections. Systemic corticosteroids
Use of any investigational drugs within 1 month, or five half-lives, whichever is longer, of the study procedures
Presence of any current suicidality or a lifetime history of suicide attempt or suicidal ideation within the past year
History of serious mental illnesses including psychotic disorders, bipolar disorders, severe anxiety, mood, or trauma-related disorders and other psychiatric conditions which in the opinion of the investigators would impede the patient's participation or compliance in the study
History of liver decompensation events such as hepatic encephalopathy or ascites
History of severe gastroparesis

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.