In another win for its obesity blockbuster, Novo Nordisk announced that Wegovy (once-weekly semaglutide 2.4 mg) bested placebo in a phase 3 trial of adults with heart failure with preserved ejection fraction (HFpEF) and obesity.
HFpEF is the most common form of heart failure, comprising about half of all cases, and is associated with a high burden of physical limitations affecting daily life, including fatigue, shortness of breath, reduced ability to exercise, and swelling of extremities.
The phase 3 STEP HFpEF trial included 529 people with symptomatic HFpEF and obesity. Those who took Wegovy saw a 13.3% mean weight reduction and had a 16.6 point improvement on a 100-point health scale based on a range of heart failure-related criteria. Those in the placebo group saw a 2.6% weight reduction and an 8.7 point improvement on the health scale.
The news comes on top of positive results shared earlier this month, where Wegovy reduced the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in a large international trial. 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 the standard of care for the prevention of major adverse cardiovascular events (MACEs) over a period of up to five years.
Collectively, the two trials reinforce the potential of Wegovy to enhance cardiovascular care. This will further build Novo's case for the medicine's health benefits beyond weight loss, making payers more likely to cover the drug.
Approved in June 2021, Wegovy is a GLP-1 receptor agonist that is currently on track to bring in $4 billion in U.S. sales alone this year, despite both coverage and supply constraints.
