Phase 2Not yet recruiting
Semaglutide for the treatment of visceral obesity in people with HIV with body mass index <30 kg/m2 and without diabetes: a randomized clinical trial to explore immune metabolism, systemic and vascular inflammation assessed with Positron Emission Tomography (SHAPE)
- Sponsor
- Azienda Ospedaliero Universitaria Di Modena (Academic or other)
- Enrollment
- 66 planned
- Conditions
- Adult subjects with HIV infection on stable antiretroviral therapy.; HIV infection
- Interventions
- Wegovy 0.25 mg FlexTouch solution for injection in pre-filled pen; Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen; Wegovy 1 mg FlexTouch solution for injection in pre-filled pen; Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen; Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen
- Ages
- adults, older adults
- Registry
- CTIS2026-526738-18-00
Full record on the EU Clinical Trials Information System
From the registry
Main objective: To determine whether semaglutide, added to a structured lifestyle intervention, produces a greater percentage reduction in visceral adipose tissue at 12 months than the structured lifestyle intervention alone, among PWH with DEXA-derived VAT area ≥140 cm2, BMI ≥25 and <30 kg/m2, and no diabetes.
Primary outcomes
- Percentage change in visceral adipose tissue (VAT area, cm2) from baseline to Month 12, measured by whole-body DEXA and assessed by readers blinded to treatment allocation.
History
Registered