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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 27, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT04019197). This is a study registration, not published results. Lead sponsor: Case Western Reserve University. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 108 participants (ACTUAL). Conditions: HIV/AIDS, Lipohypertrophy, Obesity. Interventions: DRUG: Semaglutide Injectable Product; DRUG: Placebo. Primary outcome measures: Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline , 32 weeks; Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline , 32 weeks; Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline , 32 weeks. Brief 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.