Semaglutide and Vascular Regeneration

What this study is testing ClinicalTrials.gov NCT05870462 ↗

Description as written by the study sponsor.

SEMA-VR is a prospective, randomized, 6-month long, open-label study of semaglutide. Approximately 100 participants with type 2 diabetes and/or obesity will be randomized (1:1) to receive semaglutide at escalating doses (up to 1.0 mg/week) or usual care without semaglutide for 6 months. The goal of this trial is to understand how semaglutide exerts cardio-protective effects in people with type 2 diabetes and/or obesity. The main question it aims to answer is: • Does semaglutide treatment preserve or increase the number of vessel-repairing cells circulating in the blood? Participants will: * Be allocated to receive either semaglutide or usual care for 6 months * Provide a blood sample at the baseline visit and another blood sample at the 6-month visit Researchers will compare participants receiving semaglutide to those receiving usual care for any differences in the 6-month change in the number of vessel-repairing cells in the blood.

Treatments tested

• Semaglutide Pen Injector also known as Ozempic, Wegovy Drug

  * 0.25 mg/week (non-therapeutic dose) during Weeks 1-4 * 0.50 mg/week during Weeks 5-8 * 1.0 mg/week during Weeks 9-24 Participants experiencing side effects (e.g. nausea, stomach pain, constipation, diarrhea, vomiting) at the maximum dose (1.0 mg/week) may be down-titrated to 0.50 mg/week. Participants who had been receiving a dipeptidyl peptidase 4 (DPP-4) inhibitor (sitagliptin, saxagliptin, linagliptin, alogliptin) will stop taking their DPP-4 inhibitor upon randomization to this arm.