Denmark – based pharmaceutical giant Novo Nordisk A / S (NYSE: NVO) has announced topline results from a Phase Ib / IIa study of its investigational drug amycretin, a unimolecular GLP – 1 and amylin receptor agonist. The study was designed to evaluate the safety, tolerability, pharmacokinetics, and proof – of – concept of amycretin in subjects with overweight or obesity.
Study Design and Results
The study enrolled 125 participants with overweight or obesity and assessed the effects of once – weekly subcutaneous administrations of amycretin. The trial featured three different maintenance doses, with a total treatment duration of up to 36 weeks. Results indicated that amycretin’s safety profile was consistent with other incretin – based therapies, with the most common adverse events being gastrointestinal in nature and predominantly mild to moderate in severity.
Significant weight loss was observed in subjects treated with amycretin. Participants receiving 1.25mg of amycretin achieved an estimated body weight loss of 9.7% after 20 weeks. Those treated with 5mg experienced a 16.2% weight loss after 28 weeks, while the 20mg dose resulted in a 22.0% weight loss after 36 weeks. In contrast, individuals treated with placebo experienced an estimated body weight gain of 1.9%, 2.3%, and 2.0% respectively across the different time points.
Potential Applications and Development
Amycretin is being developed as an efficacious and convenient treatment option for adults with overweight or obesity, as well as for those with type 2 diabetes. The drug is designed for both oral and subcutaneous administration, offering flexibility in treatment delivery. The promising results from this Phase Ib / IIa study highlight amycretin’s potential to address significant unmet medical needs in both obesity and diabetes management.-Fineline Info & Tech
Leave a Reply