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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526738-18-00

Enrollment

Registered

2026-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult subjects with HIV infection on stable antiretroviral therapy.

Brief summary

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.

Detailed description

Proportion of participants achieving a reduction of at least 30% in VAT at 12 months. Changes in: body composition, weight and BMI, MASLD, incident diabetes and cardiovascular disease, physical performance and frailty, patient-reported outcomes, immune-metabolic phenotyping, inflammatory biomarkers, and vascular inflammation by [18F] FDG-PET.

Interventions

DRUGWegovy 0.25 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 1.7 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 1 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 0.5 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 2.4 mg FlexTouch solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Proportion of participants achieving a reduction of at least 30% in VAT at 12 months. Changes in: body composition, weight and BMI, MASLD, incident diabetes and cardiovascular disease, physical performance and frailty, patient-reported outcomes, immune-metabolic phenotyping, inflammatory biomarkers, and vascular inflammation by [18F] FDG-PET.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 13, 2026