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Could ozempic help people with HIV shed pounds?

NCT ID NCT04174755

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether semaglutide (Ozempic) helps people with HIV and obesity lose more weight than diet and exercise alone. About 80 participants will receive either semaglutide injections or standard lifestyle advice for 28 weeks. Researchers will also check how the drug affects immune function and metabolism.

What this could mean

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

Active substance
Semaglutide (Ozempic)
What this could lead to
If it works, this could offer a new weight-loss option for people with HIV who struggle with obesity.
What could go wrong
This is a small, early-stage study with only 80 participants, so results may not apply to everyone. Semaglutide can cause side effects like nausea and vomiting.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

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

Started

Jun 2022

Expected to finish

Jul 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 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: * Be over 18 years old * Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay * Be stable on ART with a viral load suppressed \<40 copies/mL for a minimum of 2 years * Have a CD4 count ≥200 cells/mm3 for a minimum of 1 year * Have a BMI ≥30kg/m2 or have a BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus * Understand the study procedures, be able to comply with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial Exclusion Criteria: * Subjects unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide * History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma * History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine). * Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin) * History of severe renal impairment, as defined by a baseline creatinine clearance \<30ml/min * Individuals with a diagnosis of HIV-associated lipoatrophy/lipodystrophy, based on physician's assessment * Individuals with severe hepatic impairment (Child Pugh score \>9) * Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection * Any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study * History of cancer (apart from treated Kaposi's Sarcoma) and/or receiving chemotherapy or radiotherapy * Active illicit intravenous drug use * Subjects concurrently enrolled in another clinical trial of an investigational medicinal product. * The investigator may decide that a subject cannot proceed in the study if there is any relevant other abnormal results in the screening assessments * Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide * Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited/cautioned concomitant medications/therapies section) * For female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study

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Conditions

The condition(s) this trial relates to.

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

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, Dublin, D07 R2WY, Ireland

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