Oral semaglutide linked to significant weight loss as Novo Nordisk awaits FDA approval
Oral semaglutide can help overweight and obese patients lose significant weight, according to new data published in The New England Journal of Medicine.[1]
Semaglutide is a GLP-1 receptor agonist sold by Novo Nordisk under the brand names Wegovy and Ozempic. It has already been associated with a long list of health benefits, including weight loss. However, the U.S. Food and Drug Administration (FDA) has yet to approve an oral GLP-1 therapy for chronic weight management. Novo Nordisk is hoping oral semaglutide will be the first drug to receive such an approval.
“The reasons patients may prefer oral administration over the subcutaneous route are most often needle aversion and local skin reactions,” wrote first author Sean Wharton, MD, an obesity specialist and medical director of the Wharton Medical Clinic, and colleagues. “In addition, unlike injectable agents, oral agents may not require a refrigerated chain of delivery and could widen the reach of obesity care in many regions of the world where a lack of refrigeration represents a barrier to access.”
For this study, Wharton et al. tracked data from 205 patients who were randomized to either receive oral semaglutide or a placebo for 64 weeks. All oral semaglutide was given to patients as a 25-mg dose. A majority of patients were women. Overall, the mean change in body weight was -13.6% for oral semaglutide and -2.2% for the placebo. Oral semaglutide was also linked to better Impact of Weight on Quality of Life–Lite Clinical Trials Version Physical Function scores and significant improvements in both BMI and waist circumference.
The group did note that adverse events were more common among patients treated with oral semaglutide. These were primarily “mild or moderate” and able to be resolved without permanently discontinuing treatment. Gastrointestinal issues such as nausea and vomiting were the most common adverse events.
Research presented at ACC.25 and then simultaneously published in The New England Journal of Medicine highlighted the potential cardiovascular benefits of oral semaglutide for patients with type 2 diabetes.[2]
Novo Nordisk anticipates FDA approval for oral semaglutide
Novo Nordisk funded this analysis. The company also issued a statement celebrating the study’s findings and emphasizing that oral semaglutide has already been submitted to the FDA for approval.
“Currently, less than 2% of individuals with obesity in the U.S. receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” Martin Holst Lange, Novo Nordisk’s chief scientific officer and executive vice president of research and development, said in the statement. “Pending FDA approval, ample supply will be available to meet the expected U.S. demand as we hope to set a new treatment benchmark for oral weight loss medications for people with overweight or obesity.”
Novo Nordisk also revealed that oral semaglutide is already being produced at various U.S. facilities.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.