Effects of Semaglutide in HIV-Associated Lipohypertrophy

What Was Tested

The trial (phase 2) is built around Semaglutide.

This is a randomized, double-blinded, placebo-controlled trial designed to assess the effect of the GLP-1 receptor agonist, semaglutide, on visceral and ectopic fat, insulin resistance, inflammation markers, and the downstream effect of cardiovascular risk in people with HIV.

The primary endpoints will be visceral and ectopic fat changes over the study period.

The secondary endpoints will include changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.

It had two arms (groups): Participants with HIV and lipohypertrophy: semaglutide arm (experimental) and Participants with HIV and lipohypertrophy: placebo arm (placebo comparator).

Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.

The registry classes the interventions as drug.

More on the Plan

This study is a phase IIb, randomized, double-blinded, placebo-controlled clinical trial of semaglutide in people with HIV-associated lipohypertrophy.

Participants will be recruited from 1 site (Cleveland, OH).

The duration of the study will be 56 weeks.

The interventional phase will last 32 weeks, followed by a 24-week observational phase to assess the sustainability of the intervention.

Who Took Part

Enrollment: 108 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female, aged ≥18 years. Body mass index ≥25 kg/m2. Waist circumference and waist-to-hip ratio \>95 cm and \>0.94 cm, respectively, for men, and \>94 cm and \>0.88 cm, respectively, for women occurring in the context of HIV treatment. HIV-1 RNA \<400 copies/mL for ≥6 months. Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.

The full record lists 13 inclusion and 16 exclusion criteria; among the exclusions: any active or chronic uncontrolled inflammatory condition, infection or cancer; women who are pregnant or breastfeeding; women with a positive pregnancy test on enrollment or prior to study drug administration.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-05-16 with completion listed for 2024-04-30.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline (time frame: 32 weeks). Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline (time frame: 32 weeks). Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline (time frame: 32 weeks).

It also tracked 46 secondary outcomes, for example Effects of Semaglutide on Liver Fat at Week 32 Compared to Baseline, Effects of Semaglutide on Quantity of Lean Body Mass at Week 32 Compared to Baseline, Effects of Semaglutide on Quantity of Total Right Psoas Muscle at Week 32 Compared to Baseline, Effects of Semaglutide on Quality of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline, Effects of Semaglutide on Quality of Pericardial Fat at Week 32 Compared to Baseline and Effects of Semaglutide on Quality of Total Right Psoas Muscle at Week 32 Compared to Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 108 people.

Its status is active not recruiting; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.