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On August 8, Novo Nordisk announced the main results of the cardiovascular outcomes trial SELECT. This double-blind trial aimed to evaluate the effect of once-weekly subcutaneous injection of semaglutide (2.4 mg) in reducing the risk of major adverse cardiovascular events (MACE) in patients who are overweight or obese with cardiovascular disease but without diabetes. The trial achieved its primary objective, showing a statistically significant 20% reduction in MACE among patients treated with semaglutide (2.4 mg) compared to placebo.
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SELECT is a randomized, double-blind, parallel-group, placebo-controlled Phase III trial designed to evaluate the efficacy of semaglutide 2.4mg compared to placebo as an adjunct to standard care in reducing the risk of MACE in patients with cardiovascular disease, overweight or obesity, and no history of diabetes. The trial enrolled 17,604 adults aged 45 years or older with overweight or obesity and cardiovascular disease (CVD) but no history of diabetes. The primary objective of the trial is to demonstrate the superiority of semaglutide 2.4mg over placebo in reducing the composite three-point MACE consisting of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
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Source: Novo Nordisk Official Website
Novo Nordisk is expected to apply for regulatory approval in the U.S. and EU in 2023 to expand the new indication of semaglutide 2.4 mg (Wegovy®). Detailed results of SELECT will be presented at a scientific conference later in 2023.
"Obese people are at increased risk of cardiovascular disease, but so far, no approved weight management drug has been shown to effectively control weight while reducing the risk of heart attack, stroke, or cardiovascular death," said Martin Holst Lange, Novo Nordisk’s Executive Vice President for Development. "Therefore, we are very excited about the results of SELECT. SELECT is a landmark trial that demonstrates the potential of 2.4 mg semaglutide to change perceptions and treatment approaches to obesity."
References:
Novo Nordisk A/S: Semaglutide 2.4 mg Reduces the Risk of Major Adverse Cardiovascular Events by 20% in Adults with Overweight or Obesity in the SELECT Trial (Source: Novo Nordisk Official Website)
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