The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s application to market a new formulation of the drugmaker’s type 2 diabetes drug Ozempic (semaglutide) as a once-weekly injection for weight loss, according to a press release from the company.
Sold under the brand name Wegovy, the new formulation for weight loss is an injection of 2.4 milligrams of semaglutide — compared with an injection of 0.5 milligrams or 1 milligram for Ozempic, the diabetes treatment. Wegovy is intended to be combined with a reduced-calorie diet and increased physical activity to achieve weight loss in people who are overweight or obese, and who have medical problems related to their excess body weight.
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As Novo Nordisk notes in the press release, the new FDA approval is based on the results of a clinical trial called STEP (Semaglutide Treatment Effect in People with Obesity) that included about 4,500 participants. Trial participants who received Wegovy lost an average of 14.9% of their body weight over the course of 68 weeks, compared with 2.4% for [participants who received a placebo (inactive treatment). Both groups followed a reduced-calorie meal plan and got physical activity as part of the trial. What’s more, 83.5% of participants in the Wegovy group lost at least 5% of their body weight, compared with just 31.1% who lost this much body weight in the placebo group.
“This is the first time we have seen this magnitude of weight loss with a medicine,” said Robert F. Kushner, MD, a professor of medicine and medical education at Northwestern Medicine’s Feinberg School of Medicine in Chicago, in the press release. “The approval of Wegovy represents a turning point for healthcare providers to embrace medical management of obesity.”
Wegovy should not be taken with any other products that contain semaglutide — such as Ozempic or Rybelsus, which is taken by mouth — or any other drug in the GLP-1 receptor agonist family, which includes Trulicity (dulaglutide), Byetta and Bydureon (exenatide), Victoza (liraglutide), and Adlyxin (lixisenatide). Like many other drugs in this family, digestive upset is the most common category of side effects for Wegovy — including nausea, diarrhea, vomiting, constipation, and stomach pain or discomfort.
As noted in a Medscape article on the FDA approval, there is an ongoing trial designed to look at cardiovascular outcomes from taking semaglutide (for 2.5 to 5 years, at a dose up to 2.4 milligrams) in people who are overweight or obese, which is expected to be completed in 2023. Novo Nordisk also plans to start a 68-week trial this year, designed to look at weight loss, in which 1,000 overweight or obese people will take an oral formulation of semaglutide.
Want to learn more about weight management? Read “Tried-and-True Weight-Loss Techniques,” “Weight-Loss Plateaus: Why They Happen and What to Do About Them,” and “Why Can’t I Lose Weight?”
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