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Could a tiny dose of a diabetes drug stop weight regain in HIV patients?

NCT ID NCT07325500

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a very low dose of semaglutide (a drug used for weight loss and diabetes) can help people with HIV avoid regaining weight after an initial weight-loss period. About 30 adults with HIV who are on stable HIV treatment and are overweight or obese will take part. The goal is to see if this approach is safe and effective for long-term weight management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

Feb 2026

Expected to finish

Jun 2029

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 years and older

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: * Confirmed human immunodeficiency virus type 1 (HIV-1) * On antiretroviral therapy (ART) for greater than or equal to 24 weeks prior to entry and no change in regimen in the 12 weeks prior to entry or planned change for the study duration * HIV-1 ribonucleic acid (RNA) \<200 copies/mL at screening * BMI greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 if also with greater than or equal to 1 weight-related comorbidity * If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for greater than or equal to 12 weeks prior to entry and no plans to dose escalate for the study duration * All participants must be willing and able to provide written informed consent and undergo all required study procedures Exclusion Criteria: * Weight greater than or equal to 400 pounds \[due to dual X-ray absorptiometry (DXA) machine limitations\] or unexplained weight change greater than or equal to 5% in the 12 weeks prior to entry * Diagnosis of or on treatment for diabetes mellitus (stable metformin dosing for pre-diabetes not excluded) * Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period * Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period * Active eating disorder * Use of human growth hormone, tesamorelin or anabolic steroids \<12 weeks prior to entry, unless on a stable dose for \>24 weeks prior to entry, or plans to start any of these medications while on study * Active, severe delayed gastric emptying * Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study * Known retinopathy * Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 * Untreated, poorly controlled or previously undiagnosed thyroid disease * Chronic pancreatitis * Known allergy/sensitivity to Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) * Poorly controlled or previously undiagnosed thyroid disease, defined as thyroid-stimulating hormone (TSH) \<0.5 or \>10 milli-international units per liter (mIU/L) at screening * Active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements * Pregnancy, nursing or plans for either during the study period * Use of planned use of any immunomodulatory therapy HIV vaccine, investigational therapy or tumor necrosis factor (TNF-α) therapy during the study period * Current serious illness requiring systemic treatment and/or hospitalization, in the opinion of site investigator

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Obesity Weight Gain

As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.