Novo Nordisk to expand obesity study into oral treatment
pharmafile | April 22, 2021 | News story | | Novo Nordisk, obesity
Novo Nordisk is planning to initiate a Phase IIIa study of oral semaglutide in obesity, expanding on its Phase IIIa clinical programme – STEP – which was evaluating once-weekly subcutaneous semaglutide 2.4mg.
The newly announced Phase IIIa study of oral semaglutide 50mg 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 a placebo.
Martin Holst Lange, Executive Vice President of Development at Novo Nordisk, said: “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.
“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.”
The company’s Phase IIIa clinical trial investigating the efficacy of subcutaneous semaglutide yielded positive results, with data presented at the virtual Endocrine Society (ENDO) 2021 Annual Meeting and published in the Journal of the American Medical Association in March.
In this study, patients that were treated with once-weekly subcutaneous semaglutide had an average reduction in body weight from the baseline of 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.
Once-weekly subcutaneous 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.
Oral semaglutide (at 7mg and 14mg) has already been approved as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes in the US, EU, and Japan, under the trade name Rybelsus. The approval of Rybelsus was based on the results from 10 clinical trials which included 9,543 adults with type 2 diabetes. Rybelsus demonstrated a safe and well-tolerated profile across the clinical trials, with the most common adverse event being mild to moderate nausea which diminished over time.
Kat Jenkins
Related Content
FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as …
BioMed X and Novo Nordisk partner on oral peptide drug delivery innovation
BioMed X has announced a new collaboration with Novo Nordisk to improve oral delivery of …
Lilly reports positive results from trial of obesity candidate
Eli Lilly and Company (Lilly) has announced topline results from its phase 3 ATTAIN-1 trial, …
