Clinical Trials

Novo Nordisk’s diabetes treatment Rybelsus (semaglutide) has been found to significantly reduce the risk of major adverse cardiovascular events (MACE).

The phase 3b SOUL cardiovascular outcomes trial involved adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD).

Initiated in 2019, the study 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.

Moreover, each component of MACE was reduced, namely CV death, nonfatal myocardial infarction and non-fatal stroke.

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 at UT Southwestern, US, and SOUL steering committee co-chair, said: “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.”

The 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.

Luanched in Euorpe in 2020, Rybelsus is a GLP1 receptor agonist indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control when taken as an adjunct to diet and exercise.

Based on the SOUL findings, Novo has submitted CV event risk reduction label extension applications for Rybelsus to both US and European regulatory authorities.

Martin Holst Lange, executive vice president for development at Novo Nordisk, said: “Novo Nordisk continues to evolve its focus beyond diabetes and obesity towards a broader spectrum of metabolic and cardiovascular health.

“These data… reinforce the comprehensive set of health benefits of semaglutide, making it a strong option for healthcare professionals addressing the spectrum of metabolic and cardiovascular health – and our continued leadership in the space.”