GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular, addiction, other_emerging
- Who it enrolls
- age 18 Years to 89 Years; excludes diabetes; BMI ≥23 required; non-obese participants included; conditions: HIV; Alcohol; Smoking Cigarette; Cardiovascular Disease Prevention
- Interventions
- Semaglutide (Rybelsus®); Placebo
- Conditions
- HIV; Alcohol; Smoking Cigarette; Cardiovascular Disease Prevention
- Phase and size
- Phase 2 · 200 participants
- Dates
- Start 2026-04-17
Primary completion 2029-10-31 - Sponsor
- Vanderbilt University Medical Center (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Average drinks/week past 30 days at 3 months3 Months
02Eligibility
Who can take part
Inclusion Criteria: * 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 Exclusion Criteria: * Known allergy to semaglutide * Currently taking GLP-1 RA (in the past 3 months) * 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 * 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
03Change log
Registry changes
No changes recorded since the trial was added.