Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.
Novo Nordisk has asked the FDA to expand the indication for its type 2 diabetes drug semaglutide (Ozempic) after a study sponsored by the company showed significant weight loss in patients without diabetes.
Overweight and obese people taking Ozempic had a “sustained, clinical relevant reduction in body weight,” according to the doule-blind, placebo-controlled study published in the Feb. 10, 2021, issue of the New England Journal of Medicine. The results from that study are the basis for the company’s application for the expanded indication for Ozempic.
Semaglutide is an glucagon-like peptide-1 (GLP-1) agonist. Other drugs in that class include dulaglutide (Trulicity), liraglutide (Victoza) and exenatide (Byettta).
According to the results reported in NEJM, the injection of 2.4 mg of semaglutide once weekly plus lifestyle intervention resulted in a mean loss in body weight of 14.9% from baseline in the study volunteers who were treated with semaglutide group compared with a 2.4% loss of body weight among those who were treated with a placebo.
The study included nearly 2,000 adults who had tried to lose weight by changing their diets and either had a BMI of 30 or greater (the standard definition of obesity or a BMI of 27 or greater with one or more treated or untreated weight-related conditions, such as high blood pressure, high LDL cholesterol level or obstructive sleep apnea
“Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease ,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, in a press release. "We are excited about the regulatory filing of semaglutide 2.4 mg in the U.S. and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity."
More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (86.4% vs. 31.5%), 10% or more (69.1% vs. 12%), and 15% or more (50.5% vs. 4.9%) at week 68 (P<0.001 for all three comparisons of odds).
Participants who received semaglutide had a greater improvement in cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo.
Nausea and diarrhea were the most common adverse events associated with semaglutide, but they were typically transient and mild-to-moderate in severity, according to the authors.
More participants in the semaglutide group than in the placebo group discontinued treatment due to gastrointestinal events (4.5% vs. 0.8%).