NCT07221214

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. 1.Does semaglutide lower the average number of alcoholic beverages participants drink per week?
  2. 2.Does semaglutide lower the average number of cigarettes participants smoke per day?
  3. 3.Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and/or smoke tobacco?
  4. 4.Take semaglutide for 3 months
  5. 5.Visit the research clinic 3 times for checkups and tests
  6. 6.Provide blood samples, stool samples, and saliva samples for tests.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 hiv

Timeline
51mo left

Started Apr 2026

Typical duration for phase_2 hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Jul 2030

First Submitted

Initial submission to the registry

October 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 17, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

October 23, 2025

Last Update Submit

April 22, 2026

Conditions

HIVAlcoholSmoking CigaretteCardiovascular Disease Prevention

Keywords

HIValcoholsmokingtobaccocardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Average drinks/week past 30 days at 3 months

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

    3 Months

Secondary Outcomes (2)

  • Average cigarettes per day (cpd) past 30 days at 3 months

    3 Months

  • Systemic inflammation (IL-6) at 3 months

    6 Months

Study Arms (2)

Semaglutide

EXPERIMENTAL

drug intervention

Drug: Semaglutide (Rybelsus®)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Semaglutide (Rybelsus®)DRUG

experimental study medication

Semaglutide
PlaceboDRUG

Placebo study product

Placebo

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Cigarette SmokingSmokingCardiovascular Diseases

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Tobacco SmokingBehaviorTobacco Use

Study Officials

  • Hilary A Tindle, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilary A Tindle, MD, MPH

CONTACT

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

Rachel Jones, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 23, 2025

First Posted

October 27, 2025

Study Start

April 17, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2030

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)