SOUL study - oral semaglutide and cardiovascular outcomes in high-risk type 2 diabetes

The SOUL study (n=9,650)

• found semaglutide reduced the risk of major adverse CV events vs placebo in people with type 2 diabetes and atherosclerotic CV disease and/or chronic kidney disease (3.1 vs 3.7 events per 100 person-years, respectively; HR 0.86; 95% CI 0.77 to 0.96; P=0.006)
  
• was a double-blind, placebo-controlled, event-driven, superiority trial
  • randomly assigned participants who were 50 years of age or older, had type 2 diabetes with a glycated hemoglobin level of 6.5 to 10.0%, and had known atherosclerotic cardiovascular disease, chronic kidney disease, or both to receive either once-daily oral semaglutide (maximal dose, 14 mg) or placebo, in addition to standard care
  • primary outcome was major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), assessed in a time-to-first-event analysis

Reference:

1. McGuire DK et al; for the SOUL Study Group. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. NJEM March 29, 2025