Novo Nordisk is planning to provoke a Part IIIa examine of oral semaglutide in weight problems, the Danish pharma firm introduced yesterday.
The choice to start this examine follows the completion of one other Part IIIa medical programme – STEP – which was evaluating once-weekly subcutaneous semaglutide 2.4 mg.
As soon as-weekly subcutaneous semaglutide is at the moment being reviewed within the US and EU as a therapy for adults with weight problems, primarily based on the outcomes from the STEP programme.
On this examine, sufferers handled with once-weekly subcutaneous semaglutide had a median discount in physique weight from baseline was 14.9%, in comparison with simply 2.4% within the placebo group – reflecting a therapy distinction of 12.4%.
As well as, extra individuals within the semaglutide group in comparison with placebo achieved weight discount of 5% or extra – 86.4% and 31.5%, respectively.
Half of the individuals handled with semaglutide additionally achieved a weight discount of 15% or extra, in comparison with simply 4.9% within the placebo group.
Along with inflicting weight reduction, individuals who obtained semaglutide had a larger enchancment on cardiometabolic threat elements, in addition to a larger improve in bodily operate from baseline in comparison with placebo.
The newly introduced Part IIIa examine of oral semaglutide will embody roughly in 1,000 individuals with weight problems or chubby with comorbidities.
Novo Nordisk is planning to provoke the worldwide 68-week trial within the second half of 2021, and can examine the efficacy and security of oral semaglutide versus placebo.
“With oral semaglutide we purpose to introduce a handy and efficient therapy possibility for individuals with weight problems and healthcare suppliers enabling broader use of anti-obesity treatment,” mentioned Martin Holst Lange, govt vice chairman, improvement at Novo Nordisk.
“As a complement to our injectable anti-obesity drugs, oral semaglutide has the potential to assist extra individuals dwelling with weight problems obtain weight reduction objectives and enhance their well being,” he added.