Trial results for semaglutide in HIV-associated lipohypertrophy were posted on ClinicalTrials.gov on 2026-02-17. The study showed that semaglutide treatment led to a median reduction of -51.75 cm^2 in abdominal total adipose tissue, compared to an increase of 6.65 cm^2 in the placebo group. It also significantly reduced total body fat.
Background
The trial investigated semaglutide, a GLP-1 receptor agonist, for its effects on visceral and ectopic fat, insulin resistance, inflammation markers, and cardiovascular risk in people with HIV-associated lipohypertrophy and obesity.
Trial design
The study (NCT04019197) was a Phase 2, randomized, double-blinded, placebo-controlled trial that enrolled 108 participants. It investigated semaglutide injectable product in individuals with HIV/AIDS, lipohypertrophy, and obesity. Participants were randomized to receive either semaglutide or placebo. The primary endpoints focused on assessing changes in visceral and ectopic fat over the study period.
Key results
The trial results demonstrated significant changes in fat quantities at Week 32 compared to baseline:
- For abdominal total adipose tissue, the median change was -51.75 cm^2 for the semaglutide group compared to 6.65 cm^2 for placebo.
- For abdominal subcutaneous adipose tissue, the median change was -34.65 cm^2 for the semaglutide group compared to 3.90 cm^2 for placebo.
- For abdominal visceral adipose tissue, the median change was -9.45 cm^2 for the semaglutide group compared to 2.60 cm^2 for placebo.
- For total body fat, the median change was -4.82 kg for the semaglutide group compared to 0.25 kg for placebo.
- For limb fat, the median change was -1.79 kg for the semaglutide group compared to -0.14 kg for placebo.
- For trunk fat, the median change was -2.86 kg for the semaglutide group compared to 0.17 kg for placebo.
Key analyses showed statistically significant differences between groups:
- Effects on Quantity of Abdominal Total Adipose Tissue: β coefficient of -72.07 (95.0% CI: -109.88 to 34.26), with a p-value of 0.0001.
- Effects on Quantity of Abdominal Subcutaneous Adipose Tissue: β coefficient of -42.01 (95.0% CI: -75.49 to -8.52), with a p-value of 0.0138.
- Effects on Quantity of Abdominal Visceral Adipose Tissue: β coefficient of -30.83 (95.0% CI: -50.13 to -11.51), with a p-value of 0.0017.
- Effects on Quantity of ln(Total Body Fat, kg): β coefficient of -0.21 (95.0% CI: -0.33 to -0.08), with a p-value of 0.0009.
- Effects on Quantity of ln(Total Limb Fat, kg): β coefficient of -0.19 (95.0% CI: -0.32 to -0.05), with a p-value of 0.0065.
- Effects on Quantity of ln(Trunk Fat, kg): β coefficient of -0.24 (95.0% CI: -0.37 to -0.11), with a p-value of 0.0001.
What this means
The results from this Phase 2 trial indicate that semaglutide significantly reduced various fat deposits, including abdominal total, subcutaneous, and visceral adipose tissue, as well as total body fat, limb fat, and trunk fat, in individuals with HIV-associated lipohypertrophy. These findings suggest that semaglutide could be a promising therapeutic option for managing fat accumulation and related metabolic complications in this specific patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04019197, titled "Effects of Semaglutide in HIV-Associated Lipohypertrophy," were posted on 2026-02-17 on clinicaltrials.gov.