Tirzepatide in MetALD (NCT07046819) | Clinical Trial Compass
RecruitingPhase 2
Tirzepatide in MetALD
United States120 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range21 Years – 100 Years
SexALL
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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
✓. Current alcohol use as assessed via the TLFB (\>14 standard drinks per week for males and \>7 standard drinks per week for females on average for the last 8 weeks)
✓. Liver steatosis as determined by Fibroscan (CAP score \>240) at screening
✓. BMI \>= 25 and \<40 kg/m\^2
Exclusion criteria
What they're measuring
1
Metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score.
Timeframe: Change from baseline to week 12
Trial details
NCT IDNCT07046819
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
✕. 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