The SOUL cardiovascular outcomes trial, presented at ACC 2025, showed that Rybelsus® (oral semaglutide 14 mg) reduced the risk of major adverse cardiovascular events (MACE) by 14% compared with placebo in adults with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease.

This marks the first confirmation of cardiovascular benefit from an oral GLP-1 receptor agonist, placing oral semaglutide on par with its injectable counterparts. The benefit was driven primarily by a 26% reduction in non-fatal myocardial infarction, along with a 12% decrease in non-fatal stroke and a 7% reduction in cardiovascular death.

Adverse events were mainly gastrointestinal and consistent with earlier semaglutide studies. The cardiovascular benefits were observed across subgroups, including patients already on SGLT2 inhibitors suggesting complementary use may be safe and effective.

Novo Nordisk has submitted applications to the FDA and EMA to expand the label for Rybelsus to include cardiovascular risk reduction. Regulatory decisions are expected in 2025.

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