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

NCT07221214 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • HIV
  • Alcohol
  • Smoking Cigarette
  • Cardiovascular Disease Prevention

Interventions

DRUG

Semaglutide (Rybelsus®)

experimental study medication

DRUG

Placebo

Placebo study product

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Norton Healthcare

    collaborator OTHER

  • University of Louisville

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-17
Primary Completion
2029-07-31
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07221214 on ClinicalTrials.gov