Novo Nordisk announced the decision to enter phase 3a development in obesity with oral semaglutide 50 mg. The decision follows the completion of the STEP phase 3a clinical programme with once-weekly subcutaneous (sc) semaglutide 2.4 mg.
Novo Nordisk intends to initiate a pivotal phase 3a programme with approximately 1,000 people with obesity or overweight with comorbidities. The global 68-week trial is planned for initiation in the second half of 2021 and will investigate the efficacy and safety of oral semaglutide compared to placebo.
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. Semaglutide 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.
The submissions for regulatory review are based on the results from the STEP (Semaglutide Treatment Effect in People with obesity) phase 3 clinical development programme. The global clinical phase 3a programme consisted of four trials and enrolled approximately 4,500 adults with overweight or obesity.
