Reduce cardiovascular risk by 14%! Successful Phase III SOUL study of oral semaglutide

On October 21, 2024, Novo Nordisk announced the main results of the SOUL cardiovascular outcome trial. This double-blind randomized trial compared oral semaglutide (Rybelsus) with placebo as an adjuvant treatment of standard care to prevent major adverse cardiovascular events (MACEs). A total of 9650 patients with type 2 diabetes were recruited for the trial, who had been diagnosed with cardiovascular disease (CVD) and/or chronic kidney disease (CKD). As part of standard treatment, 49% of patients received SGLT2 inhibitors at some stage during the trial period

Compared with placebo, patients receiving oral semaglutide treatment had a 14% reduction in MACE, which was statistically significant and achieved the main objective of the trial. The primary endpoint of the study is defined as the composite outcome of the first occurrence of MACE, namely cardiovascular death, non fatal myocardial infarction, or non fatal stroke. All three components of the primary endpoint demonstrated the advantage of oral semaglutide in reducing MACE.

In this experiment, the safety and tolerability of oral semaglutide were consistent with previous trials.

We are pleased to see that the results of SOUL indicate that oral semaglutide can reduce the risk of cardiovascular events, and the benefits of oral semaglutide are achieved on the basis of standard treatment Martin Holst Lange, executive vice president and head of development department of Novo Nordisk, said: "About one third of adult patients with type 2 diabetes suffer from cardiovascular diseases at the same time; therefore, it is crucial to have a treatment that can treat these two diseases at the same time."

Novo Nordisk is expected to apply to regulatory authorities in the United States and the European Union for the indication extension of Rybelsus by the end of this year.

About semaglutide

semaglutide is a GLP-1 receptor agonist that stimulates insulin production and inhibits glucagon secretion, reducing appetite and food intake. semaglutide was initially approved for marketing as a therapeutic drug for type 2 diabetes (trade name: Ozempic). In view of its remarkable effect in weight loss, FDA approved it for the treatment of ordinary obese patients (trade name: Wegovy) in June 2021. It is the first new drug approved by the US FDA to control ordinary obesity or overweight since 2014.

The drug was later approved by the European Union for the treatment of obesity in the same year.