Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College Dublin
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Semaglutide Injectable Product
- Standard of care
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
University College Dublin
Lead sponsor
University of Copenhagen
Collaborator
Rush University Medical Center
Collaborator
Source ClinicalTrials.gov