GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
NCT ID: NCT07221214
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2026-02-06
2030-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Semaglutide
drug intervention
Semaglutide (Rybelsus®)
experimental study medication
Placebo
Placebo
Placebo study product
Interventions
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Semaglutide (Rybelsus®)
experimental study medication
Placebo
Placebo study product
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
89 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Norton Healthcare
OTHER
University of Louisville
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Hilary Tindle
Professor of Medicine
Principal Investigators
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Hilary A Tindle, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Central Contacts
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Other Identifiers
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