Actively Recruiting
Phase II Evaluation of Tirzepatide in Adults With Alcohol Use Disorder and Overweight or Obesity
Led by University of Southern California · Updated on 2025-10-14
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of weekly tirzepatide injections compared to placebo on alcohol use and heart-related metabolic health in adults with alcohol use disorder who also have overweight or obesity. This is a Phase 2 randomized controlled trial aiming to understand how tirzepatide might influence drinking behavior and cardiometabolic outcomes in this specific group. Participants will receive either tirzepatide injections at doses of 2.5mg or 5.0mg, or placebo injections, on a weekly basis. The study is randomized and triple-blinded to compare these two groups fairly. The treatment period lasts 8 weeks, with particular focus on the last 4 weeks to assess outcomes. During the trial, participants will attend weekly medication visits where their alcohol consumption, including number of heavy drinking days, drinks per drinking day, and alcohol cravings, will be closely monitored. Researchers will also evaluate changes in drinking risk levels and abstinent days. Safety and adherence will be tracked through regular assessments and questionnaires. The total participant involvement spans the treatment period with systematic monitoring of drinking behavior and cardiometabolic health markers.
CONDITIONS
Brief Title
Tirzepatide for Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 65 years
- Meet past-year DSM-5 criteria for alcohol use disorder with at least moderate severity (4 or more symptoms)
- Average daily alcohol consumption of at least 40g for women or 60g for men in the 28 days before baseline
- Body mass index of 27 kg/m2 or higher
- Willingness to attend weekly medication visits and complete all study procedures
- Ability to read and communicate in English
- Currently seeking treatment to reduce or stop drinking
- Stable housing status
You will not qualify if you...
- Diagnosis of another substance use disorder in the past year (except tobacco or mild cannabis use disorder)
- Recent illicit drug use or positive urine screen for illicit drugs (excluding prescribed opioid replacement therapy)
- History of significant alcohol withdrawal symptoms or hospitalization
- Recent behavioral or pharmacological treatment for alcohol use or court-mandated treatment
- History of pancreatitis or diabetes (Type 1 or 2) or diabetes-related conditions
- History of suicide attempts or current active suicidal thoughts
- Lifetime diagnosis of severe mental illness such as psychosis or bipolar disorder
- Significant anxiety or depression interfering with daily functioning unless stable or treated
- Treatment for eating disorder in the past 12 months
- Significant medical, neurological, or psychiatric illnesses that prevent safe participation
- History of liver disease or elevated liver enzymes
- History of cancer in the last 5 years except non-melanoma skin cancer
- Inability to attend weekly visits due to travel or work
- Recent weight loss over 5% before screening
- Currently enrolled in another clinical trial with investigational product
- Living with a current or former participant or someone on GLP-1RA therapy
- Planned surgery requiring anesthesia within 90 days after starting the study
- Previous treatment with tirzepatide or GLP-1RA within 6 months
- Recent use of weight loss or alcohol reduction medications
- Personal or family history of specific thyroid cancers or endocrine disorders
- Impaired kidney function (eGFR less than 60)
- Use of medications unsafe with tirzepatide as judged by study physicians
- Known bone, muscle, or wasting conditions
- Significant gastrointestinal conditions interfering with treatment
- Pregnancy, nursing, or inability to use reliable birth control (for women of childbearing age)
- Uncontrolled high blood pressure
- Recent heart attack or stroke within 6 months
- Alcohol consumption reduced below study thresholds before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 8 weeks
Participants receive weekly injections of tirzepatide or placebo and attend medication visits while their alcohol use and health are monitored.
Weekly visits for medication and assessments
Trial Site Locations
Total: 1 location
1
Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90032
Actively Recruiting
Research Team
C
Christian Hendershot, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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