Health TrialsbyHealthPanel

Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV

ConditionsObesityHIV-1-infection
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Semaglutide Injectable Product

    Drug

    Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.

  • Standard of care

    Behavioral

    Diet and exercise advice for 40 weeks

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Semaglutide 0.25/0.5/1 mg plus standard of careExperimental treatment 2 interventions
Group B: Standard of care aloneOther 1 intervention

Trial outcomes

Primary outcomes

1

Changes in total body weight (in Kg)

Between-group differences in percent change from baseline to week 28 in total body weight

Time frame
28 weeks

Secondary outcomes

1

Proportion of subjects not achieving 5% weight loss from baseline to week 16

Between-group differences in number of subjects who do not achieve a 5% weight loss (in Kg) from baseline to week 16

Time frame
16 weeks
2

Changes in numbers and function of immune cell subsets

Between-group differences in percent change from baseline in numbers and functions of immune cells subsets (NK cells, MAIT cells, T-cells and Monocytes) as assessed through flow cytometry in a single assay

Time frame
40 weeks
3

Changes in quantified viral reservoir in peripheral blood mononuclear cells (PBMCs)

Between-group differences in percent change from baseline in HIV pro-viral DNA and cell-associated RNA (CA-RNA), measured in PBMCs (copies/mL)

Time frame
40 weeks
4

Changes in gut microbiome composition in stool samples

Between-group differences in percent change from baseline in gut microbiome composition (% prevalence of different microbial species) as assessed through molecular techniques in stool samples

Time frame
40 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College Dublin

Lead sponsor

University of Copenhagen

Collaborator

Rush University Medical Center

Collaborator

Source ClinicalTrials.gov
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