Scott Buzby , 2025-05-16 14:29:00
The SOUL trial compared oral semaglutide vs. placebo on top of standard care in patients with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease or both.
Read Healio’s in-depth coverage of the SOUL trial, including expert perspective.
The trial enrolled 9,650 adults aged 50 years and older with longstanding type 2 diabetes, known ASCVD, CKD or both. Patients were randomly assigned to oral semaglutide (Rybelsus, Novo Nordisk), which was gradually titrated to 14 mg, or placebo in addition to standard care.
Over a mean follow-up of 49.5 months, oral semaglutide reduced risk for major adverse CV events by 14% vs. placebo, regardless of SGLT2 inhibitor use. The safety profile of oral semaglutide was similar to that observed in previous semaglutide trials, making this the first oral GLP-1 receptor agonist to show CV benefit, according to the researchers.
The SOUL trial was presented at the 2025 American College of Cardiology Scientific Session and simultaneously published in The New England Journal of Medicine.
