Denmark-based pharmaceutical major Novo Nordisk (NYSE: NVO) announced plans to advance both subcutaneous and oral formulations of amycretin into Phase III clinical development for weight management. The decision follows the successful completion of earlier-stage studies, which showed promising results.
Amycretin’s Mechanism and Administration Options
Amycretin is a novel single-molecule dual agonist targeting the glucagon – like peptide – 1 (GLP – 1) receptor and amylin receptor. It offers both injectable and oral administration options for adults with overweight/obesity and type 2 diabetes.
Clinical Trial Results
The top-line results of Phase Ib/IIa clinical trials, released in January 2025, showed that the safety profile of amycretin is consistent with that of drugs based on intestinal secretion. The most common adverse event was gastrointestinal reactions, with the vast majority being mild to moderate.
Weight Loss Outcomes
Patients receiving treatment with amycretin experienced significant weight loss. At a dose of 1.25 milligrams over 20 weeks, patients lost approximately 9.7% of their body weight. The weight loss increased to 16.2% at a dose of 5 milligrams over 28 weeks and further to 22.0% at a dose of 20 milligrams over 36 weeks.
Significance and Future Potential
The advancement of amycretin into Phase III trials represents a major milestone in Novo Nordisk’s efforts to expand its portfolio in the weight management and diabetes markets. If successful, amycretin could potentially offer a new treatment option for patients struggling with obesity and type 2 diabetes, providing both convenience in administration and significant weight loss benefits.-Fineline Info & Tech
