The cardiovascular outcomes trial evaluated subcutaneous once-weekly semaglutide 2.4mg against placebo as an adjunct to the standard of care to prevent MACEs over a five year period
A product shot of semaglutide in a pill. (Credit: Novo Nordisk A/S)
Danish pharmaceutical company Novo Nordisk announced that semaglutide 2.4mg (Wegovy) has lowered the risk of major adverse cardiovascular events (MACEs) by 20% in overweight adults or with obesity in the SELECT trial.
Semaglutide is a subcutaneous once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist. It is indicated in the US and a few other countries as an adjunct to a minimised calorie diet and enhanced physical activity for chronic weight management in adults with obesity or in overweight adults.
The SELECT cardiovascular outcomes trial evaluated subcutaneous once-weekly semaglutide 2.4mg against placebo as an adjunct to the standard of care to prevent major adverse cardiovascular events (MACEs) over a five year period.
According to the results, the study met its primary objective with the 20% reduction in MACEs.
The study’s primary endpoint was the composite result of the first occurrence of MACE, which was defined as cardiovascular mortality, nonfatal myocardial infarction, or non-fatal stroke.
The superior MACE decrease shown by semaglutide 2.4mg was a result of the interaction between all three elements of the primary endpoint, said Novo Nordisk.
In addition, the GLP-1 receptor agonist showed a safe and well-tolerated profile in line with previous trials.
Novo Nordisk development executive vice president Martin Holst Lange said:
“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.
“SELECT is a landmark trial and has demonstrated that semaglutide 2.4mg has the potential to change how obesity is regarded and treated.”
Initiated in 2018, the SELECT trial was a randomised, double-blind, parallel-group, placebo-controlled trial that included 17,604 adults of age ≥45 years with a Body Mass Index (BMI) ≥27 kg/m2.
The effects of semaglutide 2.4mg compared to placebo on mortality, cardiovascular risk factors, glucose metabolism, body weight, and renal function were the key secondary objectives.
Novo Nordisk plans to submit for regulatory clearance of semaglutide 2.4mg (Wegovy) label indication expansion applications in the US and the European Union in 2023.