Actively Recruiting
GLP-1 Receptor Agonists to Decrease Ethanol and Cardiovascular Disease Risk in HIV - GL1DER HIV Randomized Controlled Trial
Led by Vanderbilt University Medical Center · Updated on 2026-05-26
200
Participants Needed
1
Research Sites
13 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
Researchers are studying whether the drug semaglutide can reduce alcohol consumption among adults living with HIV. The study aims to find out if semaglutide can lower the number of alcoholic drinks consumed per week, reduce the number of cigarettes smoked daily, and decrease the risk of cardiovascular disease in people with HIV who drink alcohol and/or smoke tobacco. This trial is a Phase 2 randomized study comparing semaglutide to a placebo. Participants will take semaglutide or a placebo for three months. During this time, they will visit the clinic three times for checkups and tests. Researchers will collect blood, stool, and saliva samples to monitor changes and effects. The study uses a quadruple-masked design to ensure unbiased results. Throughout the study, participants will be monitored for alcohol and cigarette use, inflammation markers, and cardiovascular risk factors. The main outcome measured is the average number of drinks per week after three months. Additional assessments include average cigarettes smoked daily and systemic inflammation levels. Participants will be followed closely during the treatment period to track these health measures.
CONDITIONS
Brief 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 antiretroviral therapy 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
- Body mass index of 23 or higher at screening
- Self-reported alcohol consumption in the past 90 days
- Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score of 3 or higher for males and 2 or higher for females
- Established stable address for receiving mail and contact for 6 months
- Willing and able to complete study procedures and follow-ups
You will not qualify if you...
- Known allergy to semaglutide
- Use of GLP-1 receptor agonist in the past 3 months
- History of diabetes
- History of pancreatitis
- History of gastroparesis
- Gallbladder disease in the past 3 months
- History or family history of medullary thyroid carcinoma
- History or family history of multiple endocrine neoplasia syndrome type 2
- Cognitive inability to consent
- Barriers to speaking, hearing, reading, or writing English
- Pregnant, breastfeeding, or planning pregnancy in the next 6 months
- Too ill to complete study procedures
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.
1 visit (in-person)
Duration - 3 months
Participants begin the trial medication or placebo as part of the treatment intervention.
Baseline visit and follow-up visits during treatment
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
R
Rachel Jones, MS
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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