Novo Nordisk’s popular weight-loss drug Wegovy significantly cut the risk of heart attack, stroke or death due to cardiovascular disease in people who do not have diabetes, according to new data from a large international clinical trial.
Patients taking semaglutide, the active ingredient in Wegovy and Ozempic, for more than three years had 20% lower risk of major cardiovascular events compared with those on placebo, and lost on average 9.4% of their body weight, compared with an average 0.9% weight loss in the placebo group, according to the new data released at the American Heart Association’s scientific conference this weekend in Philadelphia.
Copenhagen-listed shares of the Danish healthcare company
rose 3.8% on Monday. The shares also have a U.S. listing
The results mark the first time that any drug or lifestyle therapy has been shown to reduce cardiovascular events in adults with obesity or overweight who do not have diabetes, researchers said. The trial involved more than 17,500 adults in 41 countries with obesity or overweight and who had previously had a heart attack, stroke or peripheral-artery disease but who did not have Type 1 or Type 2 diabetes.
Top-line results of the study were released in August, triggering a surge in Novo Nordisk shares and contributing to a corresponding selloff in shares of many medical-device makers and other companies seen as vulnerable to the GLP-1 drug boom.
Novo Nordisk has filed for an expanded Wegovy label in the U.S. and European Union to include an indication for reducing the risk of major cardiovascular events. A regulatory decision is expected in 2024, the company said.
“We look forward to working with regulatory authorities on next steps based on the findings” of the study, Anna Windle, a senior vice president at Novo Nordisk, said in a statement.
The full trial results come as Wegovy is about to face new competition from Eli Lilly & Co.’s
obesity drug Zepbound, which was approved this week by the U.S. Food and Drug Administration. At the same time, Novo Nordisk is still struggling to meet demand for Wegovy. The company said Friday that it will invest more than $6 billion to expand manufacturing facilities for GLP-1 drugs and other products.
The trial findings could lend support to broader insurance coverage of GLP-1 drugs. The full study results were eagerly awaited by analysts and investors hoping that strong evidence of cardiovascular benefits would boost the likelihood that insurers will cover the medications.
Eli Lilly is also researching tirzepatide, the active ingredient in Zepbound, in heart failure, sleep apnea and other chronic conditions. Regulatory approval for the drug in such conditions could help expand access to the medication by Medicare, which does not cover prescription drugs for weight loss, Lilly CEO David Ricks said on a call with reporters this week.
More than half of the global population will have overweight or obesity by 2035 if prevention and treatment don’t improve, according to the World Obesity Federation, an organization of healthcare, research and policy groups, with the economic impact expected to hit $4.3 trillion worldwide.
What’s more, “most people with cardiovascular disease don’t have diabetes. Most of them have obesity alone,” Dr. Ania Jastreboff, associate professor at Yale School of Medicine and co-director of the Yale Center for Weight Management, said during a press briefing at the American Heart Association conference Friday. “So that’s critical. It’s a large population,” Jastreboff said. “There are many people who could benefit.”
Although GLP-1 drugs had been shown to cut cardiovascular risks in people with Type 2 diabetes, it wasn’t clear whether they would have the same benefits in people without diabetes. The trial results show that semaglutide’s cardiovascular-risk reduction in nondiabetic patients is the same as the benefit seen in people with Type 2 diabetes, Dr. A. Michael Lincoff, a Cleveland Clinic cardiologist and lead author of the semaglutide study, said in a statement.
Patients in the trial took a 2.4-mg weekly dose of semaglutide, the same Wegovy maximum dose that is FDA-approved for weight loss but higher than the Ozempic doses approved for treatment of Type 2 diabetes.
Weight loss alone may not fully explain the benefits of semaglutide in reducing the risk of cardiovascular events, Novo Nordisk said in a statement Saturday. The differences in rates of cardiovascular events between the trial participants taking semaglutide and those on placebo “began to emerge very early after the initiation of treatment, within the first months,” Lincoff said at the briefing Friday.
Some cardiovascular benefits were seen even “before significant weight reduction occurs,” Jastreboff said. “We really need to investigate the physiology” behind that, she said. “This is absolutely fascinating.”
While traditional methods of cutting cardiovascular risks involve treatment of high blood pressure, high cholesterol and other factors, “imagine a future — a future where we’re treating obesity and in effect treating these other obesity-related diseases,” Jastreboff said.
Only 28% of the trial participants were women. Most participants “were white, non-Hispanic men,” Jastreboff said. “We need to strive to do better in all of our trials” to represent the patients who could benefit from therapies, she said.
Novo Nordisk’s American depositary receipts have gained 49.5% in the year to date, while Eli Lilly shares are up 63.4% and the S&P 500
has climbed 15%.