Novo Nordisk has announced topline data from the SELECT trial, which suggest use of once-weekly semaglutide 2.4 mg was associated with a statistically significant 20% reduction in 3-point MACE among a cohort with overweight or obesity and established cardiovascular disease.
Use of semaglutide 2.4 mg (Wegovy) was associated with a reduction in the risk of major adverse cardiovascular events in the SELECT trial, according to an announcement from Novo Nordisk.1
Announced on August 8, 2023, topline results of the trial indicate once-weekly semaglutide 2.4 mg was associated with a 20% reduction in major adverse cardiovascular events among a cohort with established cardiovascular disease with overweight or obesity with no prior history of diabetes.1
"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 2.4 mg reduces the risk of cardiovascular events,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk.1 “SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”
Semaglutide 2.4 mg made history in June 2021 when it received approval from the US Food and Drug Administration for chronic weight management in adults with obesity or overweight—the first GLP-1 receptor agonist to receive such an indication. This approval was based on data from the STEP program, which included 4 trials examining the effects of the agent in more than 2600 patients with obese or overweight. In the STEP program, use of semaglutide 2.4 mg was associated with an average weight loss of 17-18% that was sustained over 68 weeks.2
Launched in 2017, the double-blind, parallel-group, placebo-controlled SELECT trial was born with the intent of providing a more holistic understanding of the effects of semaglutide 2.4 on overall health, particularly cardiovascular health.1
For inclusion, patients needed to be at least 45 years of age and have a BMI of 27 kg/m2 or greater. In total, the trial enrolled 17,604 adults from more than 800 investigator sites across 41 countries. The primary outcome of interest for the trial was incidence of 3-point major adverse cardiovascular events, which consisted of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. Secondary outcomes of interest for the trial included comparisons against placebo therapy for mortality, cardiovascular risk factors, glucose metabolism, body weight and renal function.1
In their announcement of topline results, Novo Nordisk noted detailed results are scheduled to be presented at a scientific conference later this year as well as plans to file for regulatory approvals of a label indication expansion in the US before the end of 2023.1