NCT07221214RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Oct 2025
- Start date
- 17 Apr 2026
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- HIV
- NCT number
- NCT07221214
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 17 Apr 2026 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking GLP-1 RA (in the past 3 months)
Other illness
- Known allergy to semaglutide
- History of diabetes defined by diagnosis in Problems List in medical record
- History of pancreatitis
- History of gastroparesis
- Gallbladder disease (in the 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
Other
- Cognitive inability to consent
- Barrier to speaking, hearing, reading, or writing English
- Pregnant or breastfeeding, or planning to become pregnant in the next 6 months
- Too ill to complete study procedures
Who the study is looking for
- Ages 18-89
- Prior diagnosis of HIV-1
- Affiliated with Vanderbilt Comprehensive Care Clinic
- On current ART regimen for at least 90 days prior to study entry with no missed doses for at least 7 consecutive days.
- Most recent absolute CD4 count ≥ 300 cells/mm3 and drawn within 12 months of study enrollment
- BMI ≥ 23 (calculated at screening)
- Self-report of consuming alcohol in past 90 days
- AUDIT-C ≥ 3 (male)/ ≥ 2 (female)
- Has an established stable address at which they can receive mail and can be reached for the next 6 months
- Willing and able to complete study procedures and follow-ups
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.