Semaglutide to reduce drinking, smoking, and heart disease risk in people with HIV
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT
This trial tests whether the diabetes drug semaglutide can help adults living with HIV drink less alcohol, smoke fewer cigarettes, and lower their heart disease risk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07221214 on ClinicalTrials.gov |
What this trial studies
Adults with HIV who report recent alcohol use will be randomized to receive semaglutide (Rybelsus®) or a matching placebo for three months and compared on alcohol use, smoking, and cardiovascular risk markers. Participants must be on stable antiretroviral therapy with a recent CD4 count ≥300 and a BMI ≥23, and they will attend three clinic visits for safety checks and outcome measurement. Blood, stool, and saliva samples will be collected to measure biological changes and standard CVD risk indicators. This is a phase 2, placebo-controlled interventional trial conducted at Vanderbilt University Medical Center.
Who should consider this trial
Good fit: Adults 18–89 with HIV who are on stable ART, have a recent CD4 ≥300, a BMI ≥23, report recent alcohol use (AUDIT‑C above screening thresholds), and receive care at the Vanderbilt clinic.
Not a fit: People with diabetes, recent GLP‑1 use, a history of pancreatitis, gastroparesis, medullary thyroid carcinoma or related family history, or those who do not drink or smoke are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, semaglutide could help people with HIV reduce alcohol and tobacco use and lower their cardiovascular disease risk.
How similar studies have performed: Early animal work and some small human studies suggest GLP‑1 receptor agonists can reduce alcohol use and addictive behaviors and large GLP‑1 trials have shown cardiovascular benefits in other populations, but using semaglutide for alcohol and smoking reduction in people with HIV is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Hilary A Tindle, MD, MPH — Vanderbilt University Medical Center
- Study coordinator: Hilary A Tindle, MD, MPH
- Email: hilary.tindle@vumc.org
- Phone: 615-875-9726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.