GL1DER HIV RCT

RecruitingPhase 2

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

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

Lead sponsor

Vanderbilt University Medical Center

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

200

Study population

Alcohol / substance use, HIV

Eligibility highlights

•BMI ≥23

Primary endpoint

•Alcohol consumption, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07221214

Org study ID1P60AA032176

Timeline

Milestones

Study first posted2025-10-27actual

Study start2026-04-17actual

Last update posted2026-05-26actual

Primary completion2029-10-31estimated

Study completion2030-01-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Alcohol / substance useHIV

Who can enroll

Minimum age18 Years

Maximum age89 Years

SexAll

Healthy volunteersNot 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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Other (unclassified)

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Average drinks/week past 30 days at 3 months

Time frame:3 Months

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:3 Months

descriptive, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Systemic inflammation (IL-6) at 3 months

Time frame:6 Months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.