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

Not Applicable

Not yet recruiting

• Conditions: HIV; Cardiovascular Disease Prevention; Smoking Cigarette; Alcohol
• Interventions: Drug: Semaglutide (Rybelsus®); Drug: Placebo

• Registration Number: NCT07221214
• Lead Sponsor: Vanderbilt University Medical Center

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 number of alcoholic beverages participants drink alcohol per month?

2. Does semaglutide lower the number of cigarettes participants smoke per month?

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-23
• Study First Submitted QC: 2025-10-23
• Last Update Submitted: 2025-10-23
• Study First Posted: 2025-10-27
• Last Update Posted: 2025-10-27
• Study Start: 2026-02-01
• Primary Completion: 2029-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 semaglutdie
• Currently taking GLP-1 RA (in the past 3 months)
• History of diabetes defined by diagnosis in Problems List in medical record
• 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
• History of pancreatitis
• History of gastroparesis
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide	Semaglutide (Rybelsus®)	drug intervention
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Average drinks/week past 30 days at 3 months	3 Months	Average drinks/week past 30 days (via Timeline Follow Back (TLFB))

Secondary Outcome Measures

Name	Time	Method
Average cigarettes per day (cpd) past 30 days at 3 months	3 Months	Average cigarettes per day in the past 30 days (via TLFB)
Systemic inflammation (IL-6) at 3 months	6 Months	Biomarker of systemic inflammation, Biomarker of gut permeability, Reynolds Risk Score, Mortality risk