Novo Nordisk's Wegovy reduced the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in a large international trial, reported the drugmaker.
The SELECT trial enrolled 17,604 adults aged 45 years or older with BMIs of 27 or greater and established cardiovascular disease with no prior history of diabetes. The study 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 achieved its primary objective by demonstrating a statistically significant and superior 20% reduction in MACE, which was defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Data in hand, the drugmaker said it expects to file for regulatory approvals of a label indication expansion in the U.S. and EU this year.
In May, Novo announced that its phase 3 trial evaluating the oral formulation of the drug had met all its primary endpoints. The drugmaker is looking to file for regulatory approval in the U.S. and Europe this year.