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GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV (GL1DER HIV RCT) Phase 2 200

Not yet recruiting
Clinical Trial NCT07221214 (GL1DER HIV RCT) is designed to study Treatment for HIV, Alcohol, Smoking Cigarette, Cardiovascular Disease Prevention. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on March 31, 2026 until the study accrues 200 participants. Led by Vanderbilt University Medical Center, this study is expected to complete by July 31, 2030. The latest data from ClinicalTrials.gov was last updated on March 16, 2026.
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...
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Official Title

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT

Conditions
HIVAlcoholSmoking CigaretteCardiovascular Disease Prevention
Other Study IDs
NCT ID Number
NCT07221214
Start Date (Actual)
2026-03-31
Last Update Posted
2026-03-16
Completion Date (Estimated)
2030-07-31
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
HIV
alcohol
smoking
tobacco
cardiovascular disease
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSemaglutide
drug intervention
Semaglutide (Rybelsus®)
experimental study medication
Placebo ComparatorPlacebo
Placebo
Placebo study product
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Average drinks/week past 30 days at 3 months
Average drinks/week past 30 days (via Timeline Follow Back (TLFB))
3 Months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Average cigarettes per day (cpd) past 30 days at 3 months
Average cigarettes per day in the past 30 days (via TLFB)
3 Months
Systemic inflammation (IL-6) at 3 months
Biomarker of systemic inflammation, Biomarker of gut permeability, Reynolds Risk Score, Mortality risk
6 Months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
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Study Responsible Party
Hilary Tindle, Principal Investigator, Professor of Medicine, Vanderbilt University Medical Center
Study Central Contact
Contact: Hilary A Tindle, MD, MPH, 615-875-9726, [email protected]
Contact: Rachel Jones, MS, 615-421-3508, [email protected]
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