Clinical Trial

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

Study acronym: GL1DER HIV RCT
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2029-07-31 -> 2029-10-31 2026-05-27
minor Completion moved earlier: 2030-07-31 -> 2030-01-31 2026-05-27
critical Recruitment opened 2026-04-29
Trial Details
NCT Number NCT07221214
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA), Norton Healthcare, University of Louisville
Conditions HIV, Alcohol, Smoking Cigarette, Cardiovascular Disease Prevention
Enrollment 200 participants
Start Date 2026-04-17
Primary Completion 2029-10-31 (estimated)
Study Completion 2030-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-26