Semaglutide randomized trial to quantify vascular-repairing cells in type 2 diabetes and obesity

Cardiovascular disease remains a leading cause of morbidity and mortality in individuals with type 2 diabetes and obesity. While GLP-1 receptor agonists like semaglutide have demonstrated significant benefits in glycemic control and weight loss, their precise mechanisms for cardioprotection extend beyond these primary effects. Emerging evidence suggests a role in vascular health, but the direct impact on vascular regeneration via circulating vessel-repairing cells (VRCs) is not fully understood. This trial aims to bridge this knowledge gap, exploring a novel pathway for semaglutide's cardiovascular benefits.

The SEMA-VR study is a prospective, randomized, 6-month, open-label clinical trial. Approximately 100 participants with type 2 diabetes and/or obesity will be randomized 1:1 to receive either semaglutide or usual care. The intervention arm receives semaglutide escalating to 1.0 mg/week SC for 6 months. The primary endpoint is the 6-month change in circulating vessel-repairing cells, measured by flow cytometry on blood samples at baseline and 6 months.