On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide) on major adverse cardiovascular events (MACE) in individuals with type 2 diabetes and established cardiovascular disease (CVD) or chronic kidney disease (CKD).
The trial enrolled 9,650 participants and showed a 14% reduction in MACE among those receiving oral semaglutide compared to a placebo, both alongside standard care. The primary endpoint included cardiovascular death, non-fatal heart attacks, and non-fatal strokes, with all components contributing to the significant benefit observed. Nearly half of the participants also received sodium-glucose co-transporter 2 (SGLT2) inhibitors at some point during the trial as a part of standard care.
The SOUL trial has shown oral semaglutide to be well-tolerated and safe. According to a company media release, Novo Nordisk plans to seek regulatory approval for expanding the label of Rybelsus® in the US and EU by early 2025 as a result of the positive trial results.