Semaglutide 2.4mg (Wegovy), a drug approved for weight loss, can reduce the risk of major adverse cardiovascular events (MACE) by 20%, according to new data released by Novo Nordisk.
SELECT is a Phase III cardiovascular outcomes trial investigating the effects of once-weekly semaglutide 2.4mg in adults with established cardiovascular disease (CVD) and overweight or obesity without diabetes.
Novo Nordisk shares rose 3% following the presentation of the results at the American Heart Association (AHA) annual Scientific Sessions in Philadelphia and publication in the New England Journal of Medicine (NEJM).
The company has announced plans to spend $6 billion to boost manufacturing capacity, in response to shortages of Wegovy and the US and UK approval of competitor weight loss drug Zepbound.
Previously reported top-line results showed semaglutide 2.4mg 20% risk reduction in MACE up to five years versus placebo. The latest findings show that risk reductions in MACE were achieved regardless of age, gender, ethnicity and starting body mass index (BMI).
The results also demonstrated that the beneficial effects in MACE risk reduction were evident soon after treatment initiation, suggesting that the effect may not be due to weight loss alone.
“For the first time, we have evidence that semaglutide 2.4mg improves cardiovascular outcomes in at-risk patients with BMI of 27 and above with established CVD, without diabetes,” said Dr Michael Lincoff, lead study author, Vice Chair for Research in the Cleveland Clinic Department of Cardiovascular Medicine, and a paid consultant for Novo Nordisk. “The three-point MACE risk reduction observed in SELECT suggests the potential for a new option in obesity treatment, addressing some of the leading causes of preventable death worldwide.”
Changing treatment of obesity
In the trial, the risk of non-fatal myocardial infarction or heart attack was reduced by 28% compared to placebo, the risk of cardiovascular death was reduced by 15%, and the risk of non-fatal stroke was reduced by 7%.
The risk of composite heart failure events, comprising cardiovascular death, urgent heart failure visits and hospitalisations, was reduced by 18% and the risk of death from any cause was reduced by 19%.
Participants in the trial who received semaglutide lost an average of 9.4% of total body weight which was sustained throughout the trial.
“This landmark study builds on more than 20 years of research in obesity, a serious chronic disease associated with severe co-morbidities and outcomes. The results from SELECT will be instrumental in changing the way we perceive and treat obesity,” said Martin Lange, Executive Vice President and Head of Development at Novo Nordisk.
Novo Nordisk has filed for a label update of Wegovy in the US and EU to include an indication for risk reduction of major adverse cardiovascular events in adults with a BMI of ≥27kg/m2 and established cardiovascular disease. A decision is expected in 2024.