Actively Recruiting
Tirzepatide in MetALD
Led by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Updated on 2026-04-03
120
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tirzepatide in MetALD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 or older
- Able to give written informed consent
- Females must have a negative urine pregnancy test, not be breastfeeding, and agree to use accepted contraception or have only female or sterilized male partners
- Males must agree to use accepted contraception
- Diagnosis of alcohol use disorder confirmed by MINI
- Current alcohol use over 14 standard drinks per week for males or over 7 for females on average in the last 8 weeks
- Liver steatosis with Fibroscan CAP score above 240 at screening
- Body mass index (BMI) between 25 and less than 40 kg/m2
- Metabolic alcohol-associated liver disease defined by at least one of five criteria: BMI 25 to less than 40 kg/m2, fasting serum glucose ≥5.6 mmol/L or HbA1c ≥5.7%, blood pressure ≥130/85 or on antihypertensive treatment, plasma triglycerides ≥1.70 mmol/L or on lipid-lowering treatment, plasma HDL-cholesterol less than 1.0 mmol/L or on lipid-lowering treatment
You will not qualify if you...
- Seeking treatment for alcohol use disorder
- History of serious allergic reaction to GLP-1RA/GIPRA drugs
- Use of GLP-1RA/GIPRA drugs within the last 3 months
- Significant or unstable cardiovascular disease in the past 12 months
- History of diabetes or HbA1c ≥6.5% at screening
- Significant or unstable liver disease unrelated to alcohol, history of cirrhosis or esophageal varices
- Platelet count less than 110,000/mm3
- Liver enzymes (ALT or AST) more than 5 times the upper normal limit
- Bilirubin twice the upper normal limit or creatinine over 2 mg/dL
- Blood clotting problems (INR >1.5, prolonged prothrombin time >3s, or platelets <75,000/mm3)
- Positive tests for HIV, Hepatitis B surface antigen, or Hepatitis C antibody
- Chronic kidney failure with glomerular filtration rate under 60 mL/min/1.73 m2
- History of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
- History of bariatric or transplant surgery
- Significant blood abnormalities (hemoglobin <8 g/dL or white blood count <1500 cells/µL)
- History of seizure disorder, epilepsy, alcohol-related seizures in the past year, uncontrolled endocrine disease, hemorrhagic stroke, cancer in past 5 years, or other major conditions preventing safe study participation
- Use of medications interfering with tirzepatide
- Use of glucose-lowering drugs like insulin or metformin in the last 30 days
- Use of medications requiring intramuscular injections or systemic corticosteroids
- Use of investigational drugs within 1 month or five half-lives before study
- Current suicidality or suicide attempt history within past year
- History of serious mental illnesses that would impede participation
- History of liver decompensation events such as encephalopathy or ascites
- History of severe gastroparesis
- History of pancreatitis in the last 5 years or chronic pancreatitis
- Contraindications for MRI if opting for imaging scans
- Pregnancy, breastfeeding, or severe liver or kidney impairment due to unknown safety of tirzepatide in these groups
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
Nada M Saleh
CONTACT
F
Falk W Lohoff, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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