Diabetes Drug Cuts Body Weight, Seeks FDA Approval as Obesity Treatment
Novo Nordisk is positioning its type 2 diabetes treatment Ozempic (semaglutide) as an anti-obesity treatment. Data published in the New England Journal of Medicine shows the once-weekly dose of the glucagon-like peptide-1 (GLP-1) analog significantly reduced weight in patients over the course of 68 weeks.
The data published in the journal showed that semaglutide provided significant weight loss benefit to adults with a body-mass index of 30 or greater who did not have diabetes. Over the course of 68 weeks of treatment, those patients who received a subcutaneous dose of 2.4 mg of semaglutide saw a mean change in body weight of -14.9%. That compared to a mean change of -2.4% in the placebo group.
Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnea, non-alcoholic fatty liver disease and cancer.
Ozempic was first approved for type 2 diabetes in 2017 as an adjunct to diet and exercise to improve glycemic control. Last year, the drug was approved to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease. An oral form of semaglutide has also been approved for type 2 diabetes sold under the brand name Rybelsus.
According to the data in the NEJM, 1082 patients who received semaglutide, about 86%, achieved weight reductions of at least 5%. Of those, 838 saw a 10% reduction and 612 saw a weight loss of more than 15%, the researchers said. Semaglutide induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake, Novo Nordisk said.
Overall, the change in body weight at the end of 68 weeks was a 15.3 kg loss, about 33.3 pounds. The placebo group saw an average weight reduction of 2.6 kg, a little under 6 pounds.
Participants who received semaglutide had a greater improvement with respect to cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo, the researchers said.
While semaglutide has been shown to be safe, the research shows more participants in the semaglutide group discontinued treatment owing to gastrointestinal events. Nausea and diarrhea were the most common adverse events described.
The research posted in NEJM should lend support to a New Drug Application Novo Nordisk filed with the U.S. Food and Drug Administration in December for semaglutide in this indication. The company anticipates a fast turn-around for this. It applied a priority review voucher to the NDA, which means the FDA will review the application within six months. The potential indication is for the treatment of obese adults (BMI greater than 30) with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity. The NDA is based on data from Novo Nordisk’s Phase III STEP (Semaglutide Treatment Effect in People with obesity) program.
“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,” Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, said in a statement. “We are excited about the regulatory filing of semaglutide 2.4 mg in the US and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity.”