HIVPhase 2GL1DER HIV RCTNCT07221214
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
A Phase 2 study testing Semaglutide (Rybelsus®) in people with HIV and Alcohol, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- HIV, Alcohol, Smoking Cigarette
- What is being tested?
- Semaglutide (Rybelsus®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to 31 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rachel Jones, MS, 615-421-3508, rachel.l.jones3@vumc.org
About this study
Official title: GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT
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:
- Does semaglutide lower the average number of alcoholic beverages participants drink per week?
- Does semaglutide lower the average number of cigarettes participants smoke per day?
- Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and/or smoke tobacco?
Read more
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:
- Take semaglutide for 3 months
- Visit the research clinic 3 times for checkups and tests
- Provide blood samples, stool samples, and saliva samples for tests.
- Conditions
- HIV, Alcohol, Smoking Cigarette, Cardiovascular Disease Prevention
- Being tested
- Semaglutide (Rybelsus®), Placebo
- Keywords
- HIV, alcohol, smoking, tobacco, cardiovascular disease
- Medical subject headings
- Cigarette Smoking, Smoking, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (Rybelsus®)Drug
experimental study medication
PlaceboDrug
Placebo study product
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | drug intervention Receives: Drug: Semaglutide (Rybelsus®) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average drinks/week past 30 days at 3 months
Average drinks/week past 30 days (via Timeline Follow Back (TLFB))
Measured: 3 Months
Secondary outcomes (2)
Average cigarettes per day (cpd) past 30 days at 3 months
Average cigarettes per day in the past 30 days (via TLFB)
Measured: 3 Months
Systemic inflammation (IL-6) at 3 months
Biomarker of systemic inflammation, Biomarker of gut permeability, Reynolds Risk Score, Mortality risk
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start17 Apr 2026
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Norton Healthcare, University of Louisville
- Responsible party
- Principal investigator, Hilary Tindle, Vanderbilt University Medical Center
- Investigators
- Hilary A Tindle, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221214
- Sponsor's protocol ID
- 1P60AA032176
- Other IDs
- 1P60AA032176
- Acronym
- GL1DER HIV RCT
- Status last verified
- May 2026
- First submitted
- 23 Oct 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT
- ClinicalTrials.gov ID
- NCT07221214
- Acronym / sponsor ID
- GL1DER HIV RCT / 1P60AA032176
- Conditions
- HIV, Alcohol, Smoking Cigarette, Cardiovascular Disease Prevention
- Keywords
- HIV, alcohol, smoking, tobacco, cardiovascular disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Norton Healthcare, University of Louisville
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does semaglutide lower the average number of alcoholic beverages participants drink per week?
- Does semaglutide lower the average number of cigarettes participants smoke per day?
- 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:
- Take semaglutide for 3 months
- Visit the research clinic 3 times for checkups and tests
- Provide blood samples, stool samples, and saliva samples for tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide (Rybelsus®)drug intervention |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (Rybelsus®)experimental study medication | Drug | Semaglutide |
| PlaceboPlacebo study product | Drug | Placebo |
Primary outcome
Average drinks/week past 30 days at 3 months
Time frame: 3 Months
Average drinks/week past 30 days (via Timeline Follow Back (TLFB))
2 secondary outcomes
Average cigarettes per day (cpd) past 30 days at 3 months
Time frame: 3 Months
Systemic inflammation (IL-6) at 3 months
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilary A Tindle, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide (Rybelsus®) in people with HIV and Alcohol, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilary A Tindle, MD, MPH (615-875-9726, hilary.tindle@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average drinks/week past 30 days at 3 months (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.