DENMARK—Novo Nordisk has announced promising results from the SOUL cardiovascular outcomes trial: a 14% reduction in major adverse cardiovascular events (MACE) among patients treated with oral semaglutide compared to those who received a placebo.

MACE includes cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, highlighting the potential of oral semaglutide to positively impact cardiovascular health.

Initiated in 2019, the SOUL trial aimed to evaluate the safety and efficacy of Rybelsus®, an oral formulation of semaglutide, in adults with type 2 diabetes.

Approved in three doses—3 mg, 7 mg, and 14 mg—Rybelsus is designed for once-daily administration to enhance glycaemic control in patients whose diabetes management is insufficient through diet and exercise alone.

A critical focus of the trial was to assess the drug’s ability to mitigate the risk of MACE in individuals with type 2 diabetes, particularly those with pre-existing cardiovascular disease (CVD) or chronic kidney disease (CKD).

The SOUL trial, which was double-blind and randomised, involved 9,650 participants diagnosed with type 2 diabetes and either CVD or CKD.

Each participant received standard medical treatment alongside either oral semaglutide or a placebo, and nearly 49% of participants were prescribed an SGLT2 inhibitor (SGLT2i) during the study.

The trial successfully met its primary objective, demonstrating a statistically significant 14% reduction in MACE among patients on oral semaglutide when compared to those on the placebo.

 This reduction in cardiovascular events was consistent across all three MACE components—cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke—thereby underscoring the comprehensive cardiovascular benefits offered by oral semaglutide.

Moreover, oral semaglutide exhibited a favorable safety profile that aligns with findings from previous studies.

No new safety concerns emerged throughout the trial, reinforcing the drug’s overall tolerability among patients.

Martin Holst Lange, Executive Vice President and Head of Development at Novo Nordisk, expressed his enthusiasm regarding the trial results.

He emphasized the significance of addressing the dual challenges presented by type 2 diabetes and cardiovascular disease, particularly since approximately one in three adults with type 2 diabetes also contend with cardiovascular complications.

Lange remarked that the cardiovascular benefits of oral semaglutide, in conjunction with standard care treatments, represent a substantial advancement in managing these interconnected health issues.

Novo Nordisk anticipates filing for regulatory approval for an expanded label for Rybelsus® in the U.S. and EU by the end of this year.

Comprehensive findings from the SOUL trial are expected to be presented at a scientific conference in 2025, further contributing to understanding oral semaglutide’s impact on cardiovascular health in individuals with type 2 diabetes.

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