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

Vanderbilt University Medical Center

Status and phase: Not yet enrolling; Phase 2

Conditions: Alcohol; Smoking Cigarette; HIV; Cardiovascular Disease Prevention

Treatments: Drug: Placebo; Drug: Semaglutide (Rybelsus®)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07221214

1P60AA032176 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

drug intervention

Treatment:

Drug: Semaglutide (Rybelsus®)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo