Novo Nordisk's experimental drug, amycretin, has shown promising results in early-stage clinical trials, leading to a surge in the company's stock. The Phase 1b/2a trial data revealed that the drug, administered as a once-weekly injection, resulted in an average weight reduction of 22% in overweight and obese participants over 36 weeks. This outcome has sparked renewed optimism in Novo Nordisk's pipeline, particularly in the competitive obesity treatment market.
The trial involved 125 participants and evaluated the safety, tolerability, and efficacy of varying doses of amycretin. Patients experienced a dose-dependent weight loss, with the highest dose (20 mg) yielding the most significant reduction. Specifically, patients starting with a mean baseline weight of 92.7 kg experienced an estimated weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22% on 20mg (36 weeks) of amycretin compared with a gain in body weight of approximately 1.9%, 2.3% and 2.0% in patients treated with placebo, respectively.
Amycretin's Mechanism of Action
Amycretin is a unimolecular agonist of both the GLP-1 and amylin receptors. GLP-1 receptor agonists are well-established in diabetes and obesity treatment, promoting satiety and reducing food intake. Amylin, a hormone released by the pancreas, complements this effect by further suppressing hunger, delaying stomach emptying, and decreasing blood glucose levels. This dual mechanism of action distinguishes amycretin from existing treatments like Wegovy, which primarily targets GLP-1.
Safety and Tolerability
The trial's primary safety endpoint was met, with amycretin demonstrating a safety profile consistent with incretin-based therapies. The most common side effects reported were gastrointestinal issues, but the vast majority were characterized as mild to moderate in severity.
Comparison to Existing and Pipeline Therapies
These results position amycretin as a potential competitor to Eli Lilly's Zepbound (tirzepatide), which has also demonstrated significant weight loss in clinical trials. While direct comparisons are limited due to differing trial designs, the early amycretin data suggest a promising efficacy profile. It is important to note that in a mid-stage trial, orforglipron showed weight loss of 14.7% over 36 weeks.
Novo Nordisk is also developing an oral formulation of amycretin. Initial results from trials of the oral version indicated a 13.1% weight reduction; however, it was associated with a higher incidence of side effects. Martin Lange, executive vice president for development at Novo Nordisk, stated that the company is "very encouraged" by the subcutaneous formulation results and is planning further clinical development of amycretin in adults with overweight or obesity.
Market Impact and Future Directions
The positive amycretin data has been well-received by investors, with Novo Nordisk's stock experiencing a notable increase. Analysts suggest that amycretin could revitalize investor confidence in the company's pipeline and provide a competitive edge in the rapidly expanding obesity treatment market. Further Phase 3 trials are needed to confirm these early findings and fully evaluate amycretin's potential as a next-generation weight loss therapy.
