Effects of Semaglutide in HIV-Associated Lipohypertrophy
Summary
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.
Timeline
- Start
- 2019-05-16
- Primary completion
- 2024-04-30
- Completion
- 2026-09-01
Outcome
Mixed primary results
paper Significant effects of semaglutide were seen over the 32-week study period in sex-adjusted multiplicative regression analyses for the primary outcome, abdominal visceral adipose tissue PMID 38964353 ↗
registry analysis (other test); Semaglutide vs Placebo; p = 0.0009; β coefficient -0.21 (95% CI -0.33 to -0.08); linear combination of regression coeff. NCT04019197 ↗
registry analysis (other test); Semaglutide vs Placebo; p = 0.13; β coefficient -0.18 (95% CI -0.41 to 0.05); linear combination of regression coeff. NCT04019197 ↗
Publications
- Atieh O, Daher J, Abboud M, Wu Q, Sattar A, Baissary J, Koberssy Z, Labbato D, Eckard AR, McComsey GA. Effects of Semaglutide on Cognitive Function in People With HIV: A Randomized, Controlled Trial. Clin Infect Dis. 2026 May 20;82(5):753-761. doi: 10.1093/cid/ciaf577.
- Funderburg NT, Ross Eckard A, Wu Q, Sattar A, Ailstock K, Cummings M, Labbato D, McComsey GA. The Effects of Semaglutide on Inflammation and Immune Activation in HIV-associated Lipohypertrophy. Open Forum Infect Dis. 2025 Mar 20;12(4):ofaf152. doi: 10.1093/ofid/ofaf152. eCollection 2025 Apr.
- Eckard AR, Wu Q, Sattar A, Ansari-Gilani K, Labbato D, Foster T, Fletcher AA, Adekunle RO, McComsey GA. Once-weekly semaglutide in people with HIV-associated lipohypertrophy: a randomised, double-blind, placebo-controlled phase 2b single-centre clinical trial. Lancet Diabetes Endocrinol. 2024 Aug;12(8):523-534. doi: 10.1016/S2213-8587(24)00150-5. Epub 2024 Jul 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Semaglutide | Peptide | 1 mg | Subcutaneous |