Could ozempic help people with HIV shed pounds?
NCT ID NCT04174755
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
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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
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Mater Misericordiae University Hospital
RECRUITINGDublin, Dublin, D07 R2WY, Ireland
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