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

What Was Tested

The trial (not phased) is built around Semaglutide for fat loss, obesity & body recomposition.

The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH).

It had two arms (groups): one (experimental) and Standard of care alone (other).

The registry classes the interventions as behavioral and drug.

More on the Plan

A randomised, controlled, parallel-group, open-label study comparing treatment with the GLP-1 analogue semaglutide in combination with lifestyle interventions to lifestyle interventions alone in obese PWH.

The study will enroll HIV-1 infected patients ≥ 18 years with BMI ≥30kg/m2 or BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be over 18 years old. 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.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: 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; 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).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

It started in 2022-06-22 with completion listed for 2027-01.

It ran at 1 site in Ireland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in total body weight (in Kg) (time frame: 28 weeks).

It also tracked 9 secondary outcomes, for example Changes in numbers and function of immune cell subsets, Changes in quantified viral reservoir in peripheral blood mononuclear cells (PBMCs), Changes in gut microbiome composition in stool samples, Changes in parameters of glucose metabolism in blood samples, Changes in parameters of lipid metabolism and Proportion of subjects reporting any adverse event.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 80 people with fat loss, obesity & body recomposition.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.