Actively Recruiting
Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
Led by University College Dublin · Updated on 2026-04-29
80
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
U
University College Dublin
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.
CONDITIONS
Official Title
Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be over 18 years old
- Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay
- Be stable on antiretroviral therapy with a viral load suppressed below 40 copies/mL for at least 2 years
- Have a CD4 count of 200 cells/mm3 or higher for at least 1 year
- Have a BMI of 30 kg/m2 or higher, or a BMI of 27 kg/m2 or higher with hypertension, dyslipidaemia, or type 2 diabetes mellitus
- Understand and agree to follow study procedures and provide written informed consent
You will not qualify if you...
- Unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide
- History of obesity caused by endocrine disorders such as hypothyroidism, Cushing's syndrome, hypogonadism, hypothalamic disorders, polycystic ovary syndrome, or insulinoma
- History of obesity caused by antipsychotic medications like olanzapine or clozapine
- Treatment with GLP-1 receptor agonists, DPP-4 inhibitors, or insulin within the last 3 months
- History of severe kidney problems with creatinine clearance below 30 ml/min
- Diagnosis of HIV-associated lipoatrophy or lipodystrophy
- Severe liver impairment (Child Pugh score over 9)
- Active hepatitis B or C infection
- Any active illness that prevents participation according to the investigator
- History of cancer except treated Kaposi's Sarcoma, or currently receiving chemotherapy or radiotherapy
- Active illicit intravenous drug use
- Participation in another clinical trial with an investigational drug
- Known or suspected allergy to semaglutide or its ingredients
- Use of other medications prescribed mainly for weight loss
- For females: pregnancy, breastfeeding, planning pregnancy, or unwillingness to use contraception during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mater Misericordiae University Hospital
Dublin, Dublin, Ireland, D07 R2WY
Actively Recruiting
Research Team
S
Stefano Savinelli, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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