August 9, 2023 — Novo Nordisk announced the headline results from the SELECT cardiovascular outcomes trial. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years. The trial enrolled 17,604 adults aged 45 years or older with overweight or obesity and established cardiovascular disease (CVD) with no prior history of diabetes.
The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo. The primary endpoint of the study was defined as the composite outcome of the first occurrence of MACE defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. All three components of the primary endpoint contributed to the superior MACE reduction demonstrated by semaglutide 2.4 mg. 1,270 first MACEs were accrued.
In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.
"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. “SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”
Novo Nordisk expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4 mg (Wegovy) in the US and the EU in 2023. The detailed results from SELECT will be presented at a scientific conference later in 2023.
About the SELECT trial
SELECT was a randomized, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to standard of care for prevention of MACE in people with established CVD with overweight or obesity with no prior history of diabetes. People included in the trial were aged ≥45 years with a BMI ≥27 kg/m2.
The primary objective of the SELECT trial was to demonstrate superiority of semaglutide 2.4 mg 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 2.4 mg 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. The SELECT trial was initiated in 2018.
Wegovy (once-weekly subcutaneous semaglutide 2.4 mg) is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with a BMI of 30 kg/m2 or greater (obesity), adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, and pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity). Wegovy® is launched in the US, Denmark, Norway and Germany.
For more information: https://www.novonordisk.com/