Phase II Evaluation of Tirzepatide in Adults With Alcohol Use Disorder and Overweight or Obesity
University of Southern California
Summary
The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms) 2. Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline 3. Body mass index ≥ 27kg/m2 4. Willingness to attend weekly medication visits and complete all study procedures 5. Ability to read and communicate in English 6. Age 21-65 7. Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking) 8. Stable housing status Exclusion Criteria: 1. Meeting past-year DSM-5 criteria for another substance use disorder (except toba…
Interventions
- DrugTirzepatide
Tirzepatide injections (2.5mg, 5.0mg)
- DrugPlacebo injections
Placebo injections
Location
- Keck School of Medicine, University of Southern CaliforniaLos Angeles, California