Novo Nordisk’s Wegovy cut the risk of serious cardiovascular complications in people with obesity and heart disease in a closely watched trial, demonstrating a particularly large effect on heart attacks, a promising new frontier for the drug.
The roughly 17,500-person Select study tested Wegovy in people with obesity and heart disease but who did not have diabetes. Weekly injections of Wegovy slashed the overall risk of heart attack, stroke and death from cardiovascular causes by 20%, according to detailed results from the trial presented Saturday at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine. Novo Nordisk disclosed topline data from the study in August.
The findings could expand insurance coverage of Wegovy, a major barrier thus far for the drug and similar GLP-1 agonists, and spur broader use of the anti-obesity drug.
“This is the first time that medication approved for chronic obesity management can be considered life saving,” said Dr. Robert Kushner, a professor of medicine in endocrinology at the Northwestern University Feinberg School of Medicine who was involved with the study.
The new data could also help the Danish pharmaceutical company maintain its lead over Eli Lilly, whose competing weight-loss drug Zepbound was approved in the U.S. earlier this week. Zepbound has been shown to help people lose more weight, but it hasn’t yet demonstrated an effect on cardiovascular outcomes.
“If you look at where the insurance companies are going to be obliged to go, they’re going to be obliged to go with the drug that reduces cardiovascular events,” said Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart who was involved with the study.
Wegovy reduced the risk of non-fatal heart attack by 28% in the five-year trial. It produced a smaller 7% reduction in the occurrence of non-fatal stroke, though few strokes were seen in the trial overall.
What’s more, Wegovy started to show a reduction in overall cardiovascular events within months of participants starting the drug, with the difference between the drug and placebo widening as the study continued.
About two-thirds of participants had blood sugar levels that put them in the range of prediabetes. Wegovy decreased progression to diabetes by 73%, suggesting the drug could be used as an early treatment. Novo’s Ozempic, which uses the same active ingredient as Wegovy, is approved for diabetes.
The study enrolled both patients whose body-mass index met the threshold for overweight or obesity, though most of the patients were considered obese.
Side effects and limitations
Almost 17% of people receiving Wegovy in the trial stopped taking the drug, mainly because of gastrointestinal issues like vomiting and diarrhea, double the rate of people who discontinued the placebo. But more people in the control group experienced serious adverse events such as cardiac disorders and medical procedures.
The discontinuations may reflect less familiarity with Wegovy among doctors involved in the study, said Kushner, who specializes in caring for patients who are overweight or have obesity. Adjusting the dosage or tweaking diet can help people navigate unpleasant side effects.
Participants also lost less weight in this study than previous ones examining Wegovy, though this study didn’t incorporate lifestyle changes and it enrolled people with different characteristics.
One limitation of the study was its lack of diversity. Nearly three-quarters of the participants were male, and even more were white. Just about 4% of participants were Black.
Regardless, doctors expect the results to increase the number of people who take Wegovy.
Seeing a diabetes drug producing positive cardiovascular and metabolic effects “opens a new door to treat obese patients with cardiovascular disease,” said Dr. George Dangas, surgical director for the structural heart program at the Mount Sinai Health System. But it could take time and energy to incorporate it into clinical practice.
“Those are good problems to have,” Dangas said. “We have something good for the patient, that’s great.”
— CNBC’s Patrick Manning contributed to this report.