McGuire 2025 — SOUL CVOT Oral Semaglutide

New England Journal of Medicine·March 29, 2025

Darren K. McGuire, Nikolaus Marx, Sharon L. Mulvagh, John E. Deanfield, Silvio E. Inzucchi, Rodica Pop-Busui, Johannes F.E. Mann, Scott S. Emerson, Neil R. Poulter

Summary

Oral semaglutide lowered MACE risk by 14% over 4 years (12.0% vs 13.8%, HR 0.86, p=0.006). Mean follow-up 47.5 months.

Study Details

Study Design

Phase 3 double-blind CVOT

Indication

CV outcomes in T2D

Intervention

Oral semaglutide 14 mg daily

Species

Human

Sample Size

9,650 subjects