A phase 3A study of oral semaglutide 50 mg is forthcoming, and follows completion of the STEP phase 3A clinical program with once-weekly subcutaneous semaglutide 2.4 mg, according to a release from the manufacturer. 

The company intends to include 1,000 people with obesity or overweight with comorbidities for a 68-week global trial, with initiations in the second half of 2021. 

“There is a significant unmet medical need within obesity treatment today. With oral semaglutide we aim to introduce a convenient and effective treatment option for people with obesity and healthcare providers enabling broader use of anti-obesity medication.” Martin Holst Lange, executive vice president, Development at Novo Nordisk, said in the release. “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.” 

Oral semaglutide (7 mg and 14 mg) is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in the US, EU and Japan, according to the release. 

Once-weekly SC semaglutide 2.4 mg is currently under regulatory review in the US and the EU as a treatment for adults with obesity. 

“The treatment is an analogue of the human glucagon-like peptide-1 (GLP-1) hormone. It induces weight loss by reducing hunger, increasing feeling of fullness and thereby helping people eat less and reduce their calorie intake,” according to the manufacturer. 


By MD /alert Staff