Tirzepatide in MetALD

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study ID
NCT07046819
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.
  • Placebo — OTHER
    A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.

Study Details

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 Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Saline
    A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.
  • Active Comparator: Tirzepatide
    A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.

Primary Outcome Measure

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. [ Time Frame: Change from baseline to week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222
Section on Clinical Genomics & Experimental Therapeutics
[email protected]
(240) 731-9681

Find similar trials in Bethesda, MD

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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