GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Vanderbilt University Medical Center
- Study ID
- NCT07221214
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Alcohol
- Cardiovascular Disease Prevention
- HIV
- Smoking Cigarette
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 89 Years
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide (Rybelsus®) — DRUGexperimental study medication
- Placebo — DRUGPlacebo study product
Study Details
The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are: 1. Does semaglutide lower the average number of alcoholic beverages participants drink per week? 2. Does semaglutide lower the average number of cigarettes participants smoke per day? 3. Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and/or smoke tobacco? Researchers will compare the effects of semaglutide to a placebo (a look-alike substance that contains no drug) to see if semaglutide works to lower the alcohol intake among participants each week. Participants will: 1. Take semaglutide for 3 months 2. Visit the research clinic 3 times for checkups and tests 3. Provide blood samples, stool samples, and saliva samples for tests.
Key Dates
- First listed
- Oct 27, 2025
- Start date
- Apr 17, 2026
- Status verified
- May 2026
- Primary completion
- Oct 31, 2029
- Completion
- Jan 31, 2030
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Semaglutidedrug intervention
- Placebo Comparator: Placebo
Primary Outcome Measure
Average drinks/week past 30 days at 3 months [ Time Frame: 3 Months ]
Central Contacts
- Hilary A Tindle, MD, MPH615-875-9726
- Rachel Jones, MS615-421-3508
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 |
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