Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity.
The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’ risk of major adverse cardiovascular events.
The most recent Phase 3a trial will test an oral 50-mg dose of the drug with roughly 1,000 volunteers who are obese or overweight with comorbidities.
The company anticipates that the 68-week study will kick off in the second half of 2021.
Novo Nordisk has also filed a new drug application with the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The company is seeking a similar indication in the European market.
“As a complement to our injectable anti-obesity medications, oral semaglutide has the potential to help more people living with obesity achieve weight loss goals and improve their health,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk, in a statement.
The company already has experience with oral semaglutide, which has won regulatory approval in the U.S., EU and Japan to improve glycemic control in people with type 2 diabetes.
Filed Under: clinical trials, Drug Discovery, Metabolic disease/endicrinology