Still, private insurers have been slow to cover Wegovy, and Medicare is barred from paying for weight-loss medications. With Wegovy costing more than $1,300 a month, the lack of insurance coverage has put the drug out of reach for many people.
The study is important because it could shift perceptions of Wegovy and similar drugs, said Andres J. Acosta, an assistant professor of medicine and a consultant in gastroenterology and hepatology at the Mayo Clinic. Previously, the medications were highlighted for their cosmetic results.
“It’s a new era,” Acosta said. “It matters because if you lose weight, your risk of dying is reduced.”
The data from the highly anticipated trial have not been published. The results released Tuesday were top-line findings, and the company said it would release detailed results at a conference later this year.
Steven Nissen, a Cleveland Clinic cardiologist, noted that while Tuesday’s announcement is promising, he wants to see the full results.
“We have to be cautious until we actually see the peer-reviewed publication,” said Nissen, who is leading a similar trial involving Eli Lilly’s Mounjaro, a diabetes drug commonly used for weight loss. “I cannot yet call this a blockbuster result because we have not seen the publication.”
The five-year study of Wegovy involved more than 17,600 patients who were at least 45 years old and were overweight or obese, with a history of heart disease. The trial compared the effects of a weekly injection of 2.4 milligrams of the drug with a placebo, along with standard care for prevention of major heart problems.
Wegovy, also known generically as semaglutide, mimics a naturally produced hormone — glucagon-like peptide-1 — that increases insulin production, suppresses appetite and slows the emptying of the stomach, creating a full feeling even when patients eat less. A previous study showed that another semaglutide drug, Ozempic, cut the risk of heart problems for diabetes patients at high risk for cardiovascular complications. The Select trial was the first large study of semaglutide in people who are obese but who do not have diabetes.
Ozempic is approved by the Food and Drug Administration for treating Type 2 diabetes, although doctors commonly prescribe it for weight loss.
Mounjaro, which is also called tirzepatide, mimics GLP-1 but also targets a second, closely related hormone called GIP, which also stimulates insulin production. Lilly is seeking FDA approval to market Mounjaro to manage weight loss as well as diabetes.
The results will probably boost Novo Nordisk’s bottom line and could brighten prospects for makers of similar medications, according to industry analysts. The results are “close to best case scenario for SELECT, should add to Wegovy and obesity market momentum,” analysts at TD Cowen said in a note. The company’s stock soared on the news, finishing Tuesday up more than 17 percent from the day before.
Martin Holst Lange, executive vice president for development at Novo Nordisk, called the Select trial a “landmark study” in the company’s statement.
“People living with obesity have an increased risk of cardiovascular disease, but to date there are no approved weight-management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death,” Lange said, adding that the new information “has the potential to change how obesity is regarded and treated.”
The company said it will seek permission from U.S. and European regulators to add the cardiovascular benefits to the drug’s label. That would allow the manufacturer to promote the drug for that use.
Novo Nordisk said the drug appeared to be safe and well tolerated, in line with previous trials. But as more people turn to blockbuster diabetes and obesity drugs, some are experiencing uncomfortable and sometimes painful side effects along with the benefits of reduced food cravings and substantial weight loss.
Doctors say the study may dramatically alter how health insurers cover the medications, similar to how they now cover bariatric surgeries, which have been shown to reduce cardiovascular risks.
In turn, widespread coverage of the drugs — even with their high price tags — could lead to lower health-care costs, with hospitals ultimately treating fewer patients suffering heart attacks and strokes, said Angela Fitch, president of the Obesity Medicine Association and co-founder of the health-care company Knownwell.
“To have insurance companies and Medicare deny coverage to a patient is a different issue after this study is published,” Fitch said. “To deny [patients] access to treatment to prevent cardiovascular events is different than one that creates weight loss.”
She added: “This is a day to remember. This really is a pivotal moment in the treatment of obesity.”