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Semaglutide for Alcohol and Cardiovascular Risk in HIV

This study is investigating if the medication semaglutide (Rybelsus®) can help reduce alcohol intake in adults living with HIV. Researchers want to see if semaglutide lowers the average number of alcoholic drinks per week and cigarettes smoked per day. They also want to know if it can decrease the risk of heart and blood vessel problems (cardiovascular disease) for people with HIV who drink alcohol or smoke. You might be able to join if you are 18-89 years old, have HIV, are receiving care at Vanderbilt Comprehensive Care Clinic, and meet other health criteria. The study will compare semaglutide to a placebo (an inactive substance) over 3 months to see its effects on alcohol consumption.

Study design
This is an interventional study planning to enroll 200 participants. It compares the effects of semaglutide to a placebo.
What's involved
Participants will take semaglutide or placebo for 3 months. The record does not specify other visits, procedures, or tests.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 3 months, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221214

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

Recruiting
PHASE2Ages 18–89InterventionalTreatment
Vanderbilt University Medical Center
~200 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Semaglutide (Rybelsus®)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average drinks/week past 30 days at 3 months
Measured over 3 Months

Conditions

HIV
Alcohol
Smoking Cigarette
Cardiovascular Disease Prevention

Explore related trials

Alcohol use disorderCardiovascular DisorderHIV InfectionTobacco Use Disorder

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Hilary A Tindle, MD, MPH · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Hilary A Tindle, MD, MPH
[email protected]
615-875-9726
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Average drinks/week past 30 days at 3 months3 Months

    Average drinks/week past 30 days (via Timeline Follow Back (TLFB))