NCT07221214 GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
| NCT ID | NCT07221214 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2026-04-17 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Hilary A Tindle, MD, MPH
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07221214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07221214 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07221214 currently recruiting?
Yes, NCT07221214 is actively recruiting participants. Contact the research team at hilary.tindle@vumc.org for enrollment information.
Where is the NCT07221214 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07221214 clinical trial?
NCT07221214 is sponsored by Vanderbilt University Medical Center. The principal investigator is Hilary A Tindle, MD, MPH at Vanderbilt University Medical Center. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.