Bagsværd: According to topline data from the SELECT study, Compared with placebo injectable semaglutide 2.4 mg reduced risk for major adverse CV events by 20% for overweight or obese people with a body mass index (BMI) >27 and established CVD.
Novo Nordisk today 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 placebo1. 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.
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