Novo Nordisk is planning to initiate a Phase IIIa study of oral semaglutide in obesity, the Danish pharma company announced yesterday.
The decision to begin this study follows the completion of another Phase IIIa clinical programme – STEP – which was evaluating once-weekly subcutaneous semaglutide 2.4 mg.
Once-weekly subcutaneous semaglutide is currently being reviewed in the US and EU as a treatment for adults with obesity, based on the results from the STEP programme.
In this study, patients treated with once-weekly subcutaneous semaglutide had an average reduction in body weight from baseline was 14.9%, compared to just 2.4% in the placebo group – reflecting a treatment difference of 12.4%.
In addition, more participants in the semaglutide group compared to placebo achieved weight reduction of 5% or more – 86.4% and 31.5%, respectively.
Half of the participants treated with semaglutide also achieved a weight reduction of 15% or more, compared to just 4.9% in the placebo group.
In addition to causing weight loss, participants who received semaglutide had a greater improvement on cardiometabolic risk factors, as well as a greater increase in physical function from baseline compared to placebo.
The newly announced Phase IIIa study of oral semaglutide will include approximately in 1,000 people with obesity or overweight with comorbidities.
Novo Nordisk is planning to initiate the global 68-week trial in the second half of 2021, and will investigate the efficacy and safety of oral semaglutide versus placebo.
“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,” said Martin Holst Lange, executive vice president, development at Novo Nordisk.
“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,” he added.