Novo Nordisk announced results from its SOUL cardiovascular outcomes trial. Rybelsus (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD).

The new phase 3b data was presented at the American College of Cardiology’s (ACC) Annual Scientific Session and Expo in Chicago, US, and was published in the New England Journal of Medicine.

Initiated in 2019, the SOUL trial assessed the effect of oral semaglutide versus placebo on cardiovascular outcomes in type 2 diabetes, CVD and/or CKD patients. It achieved its primary endpoint, demonstrating a 14% reduction in risk of MACE compared to placebo. Each component of MACE was reduced, namely CV death, nonfatal myocardial infarction and nonfatal stroke.

Novo Nordisk is a global healthcare company, specialising in developing treatments for chronic illnesses, particularly diabetes.

Rybelsus is a GLP-1 receptor agonist indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise.

When combined, cardiometabolic diseases represent the leading cause of death globally. These include cardiovascular and peripheral artery disease, type 2 diabetes and CKD. Having type 2 diabetes directly increases the risk of developing interconnected cardiometabolic diseases.

Darren McGuire, distinguished chair in cardiovascular science and teaching professor of medicine at UT Southwestern, US, and SOUL steering committee co-chair, commented: “The SOUL trial in adults with type 2 diabetes and atherosclerotic CVD and/or CKD demonstrated significant reductions in the risk of major cardiovascular events including heart attack, stroke and CV death in those treated with oral semaglutide versus placebo. The proven cardiovascular benefit reflects a profound clinical impact for our patients who now have an oral option to improve health outcomes.”