Recruiting
Phase 2

Semaglutide

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07221214

Conditions

HIV

Alcohol

Smoking Cigarette

Cardiovascular Disease Prevention

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Semaglutide (Rybelsus®)

Placebo

Study Details

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.

Conditions

HIV

Alcohol

Smoking Cigarette

Cardiovascular Disease Prevention

Study ID

NCT07221214

Start date

Apr 17, 2026

Status verified date

May, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide

drug intervention

placebo comparator: Placebo

Interventions

Semaglutide (Rybelsus®)

experimental study medication

Placebo

Placebo study product

Primary outcome measure

  • Average drinks/week past 30 days at 3 months [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Hilary A Tindle, MD, MPH

615-875-9726hilary.tindle@vumc.org

Rachel Jones, MS

615-421-3508rachel.l.jones3@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Rachel Jones, MS

615-421-3508rachel.l.jones3@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • HIV
  • alcohol
  • smoking
  • tobacco
  • cardiovascular disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-26.