GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Semaglutide (Rybelsus®)
- Placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Norton Healthcare
Collaborator
University of Louisville
Collaborator
Source ClinicalTrials.gov