NCT07221214

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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

• HIV
• Alcohol
• Smoking Cigarette
• Cardiovascular Disease Prevention

Interventions

Type	Name	Description
DRUG	Semaglutide (Rybelsus®)	experimental study medication
DRUG	Placebo	Placebo study product

Timeline

• Start date: 2026-03-31
• Primary completion: 2029-07-31
• Completion: 2030-07-31
• First posted: 2025-10-27
• Last updated: 2026-03-16

Regulatory

• FDA-regulated drug study