Could a diabetes drug curb heavy drinking in HIV patients?

NCT ID NCT07040592

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether semaglutide, a drug used for diabetes and weight loss, can help people with HIV reduce their alcohol use. Thirty participants will receive the drug along with support from a pharmacist and psychiatrist. The goal is to see if this approach is feasible, acceptable, and safe, and whether it leads to less drinking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: semaglutide
What this could lead to: If it works, this could point toward a new way to help people with HIV reduce heavy drinking, potentially improving their overall health.
What could go wrong: This is a very small, early pilot study with only 30 participants, so results may not apply broadly. The medication is being used off-label, and side effects or lack of effectiveness are possible.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * diagnosed with HIV * Receive care at the Atlanta VA Healthcare System * Age 18 or over * Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen * Have evidence of significant alcohol use: PEth \> 20ng/ml * Prescribed \>=5 medications * Have cell phone or reliable contact number * Can provide written informed consent Exclusion Criteria: * Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment * Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive * Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment) * Untreated moderate to severe opioid use disorder * Residence out of state * Inability to read or understand English * History of serious hypersensitivity or adverse reaction to study medication * Taking potentially interactive medication(s) for diabetes * BMI\<23 * Diagnosis of type 1 Diabetes * Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease * Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema * Already prescribed the pilot medication at the time of study recruitment.

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Conditions

The condition(s) this trial relates to.

alcohol abuse HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder (AUD) HIV

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a diabetes drug curb heavy drinking in HIV patients?

What the study statuses mean