NCT04174755

Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.

Detailed description

A randomised, controlled, parallel-group, open-label study comparing treatment with the GLP-1 analogue semaglutide in combination with lifestyle interventions to lifestyle interventions alone in obese PWH. The study will enroll HIV-1 infected patients ≥ 18 years with BMI ≥30kg/m2 or BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus. Primary objective: To assess the efficacy of semaglutide as an adjunct to diet and exercise in achieving greater weight loss in obese PWH as compared to diet and exercise alone. Secondary objectives: * To explore the effect of semaglutide on markers of immune function and HIV viral reservoirs in obese PWH. * To explore the effect of semaglutide on markers of glucose and lipid metabolism in obese PWH. * To explore the effect of semaglutide on markers of inflammation and gut microbial translocation in obese PWH. * To assess the safety of semaglutide in obese PWH on stable ART.

Conditions

• Obesity
• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Semaglutide Injectable Product	Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.
BEHAVIORAL	Standard of care	Diet and exercise advice for 40 weeks

Timeline

• Start date: 2022-06-22
• Primary completion: 2025-11-01
• Completion: 2026-01-01
• First posted: 2019-11-22
• Last updated: 2024-12-16

Locations

1 site across 1 country: Ireland