Results from the SELECT cardiovascular outcomes trial has revealed that semaglutide 2.4mg demonstrated a statistically significant and superior reduction in major adverse cardiovascular events (MACEs) of 20% for people treated with semaglutide 2.4mg compared to placebo. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4mg with placebo as an adjunct to standard of care for prevention of MACEs over a period of up to five years.
"People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death. Therefore, we are very excited about the results from SELECT showing that semaglutide 2.4mg reduces the risk of cardiovascular events,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “SELECT is a landmark trial and has demonstrated that semaglutide 2.4mg has the potential to change how obesity is regarded and treated.”
The primary objective of the SELECT trial was to demonstrate superiority of semaglutide 2.4mg compared to placebo with respect to reducing the incidence of three-point MACE consisting of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Key secondary objectives were to compare the effects of semaglutide 2.4mg to placebo with regards to mortality, cardiovascular risk factors, glucose metabolism, body weight and renal function. The trial enrolled 17,604 adults and has been conducted in 41 countries at more than 800 investigator sites.
Novo Nordisk revealed that more detailed results will be presented later this. In addition, the company expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4mg in the US and the EU in 2023.