Actively Recruiting
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
Led by Vanderbilt University Medical Center · Updated on 2026-04-28
200
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 89 years
- Prior diagnosis of HIV-1
- Affiliated with Vanderbilt Comprehensive Care Clinic
- On current ART regimen for at least 90 days with no missed doses for at least 7 consecutive days
- Most recent absolute CD4 count of 300 cells/mm3 or higher within 12 months of enrollment
- Body mass index (BMI) of 23 or higher
- Self-reported alcohol consumption in past 90 days
- AUDIT-C score of 3 or higher for males, or 2 or higher for females
- Has a stable address to receive mail and can be reached for 6 months
- Willing and able to complete study procedures and follow-ups
You will not qualify if you...
- Known allergy to semaglutide
- Currently taking GLP-1 receptor agonist within the past 3 months
- History of diabetes as recorded in medical problems list
- History of pancreatitis
- History of gastroparesis
- Gallbladder disease within past 3 months
- History of medullary thyroid carcinoma
- Family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia syndrome type 2
- Family history of multiple endocrine neoplasia syndrome type 2
- Unable to consent due to cognitive issues
- Barrier to speaking, hearing, reading, or writing English
- Pregnant, breastfeeding, or planning pregnancy in next 6 months
- Too ill to complete study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
H
Hilary A Tindle, MD, MPH
CONTACT
R
Rachel Jones, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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