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Could a diabetes pill help fight HIV-related obesity?

NCT ID NCT07336797

Disease control Sponsor: Abdelrahman Mahmoud Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 empagliflozin, a diabetes drug, can help people with HIV who are overweight or obese lose weight and improve metabolic health. Researchers will enroll 66 adults with HIV who are on a specific antiretroviral therapy and have a BMI over 30. Participants will receive either empagliflozin or a placebo for 6 months to measure changes in weight, cholesterol, and blood sugar.

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 66 people

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

Started

Sep 2025

Expected to finish

Dec 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 65 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: * Age \>18 years up to 65 years old. * Body Mass Index (BMI) \> 30 kg/m\^2. * Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART). * Sustained virologic suppression, defined as HIV-1 RNA \< 200 copies/mL for at least 6 months. * Current CD4 count \> 250 cells/mL. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level \> 126 mg/dL or glycated hemoglobin (HbA1c) \> 6.5% (or per ADA definition). * Renal impairment (e.g., eGFR \< 60 ml/min/1.73m\^2). * Active viral hepatitis B or C. * Hypersensitivity to empagliflozin or any of its excipients. * Pregnancy or breastfeeding. * Current use of other SGLT-2 inhibitors. * Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin). * Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects). * Known thyroid disease, defined as TSH \> 6.0 mIU/L or \< 0.35 mIU/L

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome AIDS Body Weight HIV infectious disease metabolic syndrome X Obesity obesity disorder Overweight

As listed by the trial registrant

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

HIV (human immunodeficiency virus) Metabolic syndrome Obesity & overweight

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

  • Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo

    RECRUITING

    Cairo, 11562, Egypt

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