Novo Nordisk has announced positive topline results from a Phase 1b/2a clinical trial of amycretin, a novel unimolecular GLP-1 and amylin receptor agonist. The trial, involving 125 adults with overweight or obesity, demonstrated significant weight loss with subcutaneous administration of amycretin, positioning it as a potential next-generation treatment in the competitive obesity market.
The study's primary endpoint was the assessment of treatment-emergent adverse events. The safety profile of amycretin was found to be consistent with other incretin-based therapies, with the majority of adverse events being mild to moderate gastrointestinal issues.
Weight Loss Results
Participants in the trial received once-weekly subcutaneous injections of amycretin at varying doses (1.25 mg, 5 mg, or 20 mg) for up to 36 weeks. The results indicated a dose-dependent weight loss:
- 1.25 mg: A 9.7% reduction in body weight was observed after 20 weeks.
- 5 mg: Participants experienced a 16.2% weight loss after 28 weeks.
- 20 mg: The highest dose resulted in a 22.0% reduction in body weight after 36 weeks.
In contrast, the placebo group experienced an average weight gain of 1.9% to 2.3% over the same periods. These results, according to Novo Nordisk, support the weight-lowering potential of amycretin, building upon previous findings with the oral formulation.
Expert Commentary
"We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity," said Martin Lange, executive vice president for Development at Novo Nordisk. He added that the results support the potential of amycretin, previously observed with the oral formulation, as a novel unimolecular GLP-1 and amylin receptor agonist.
Trial Design and Methodology
The Phase 1b/2a trial was a randomized, placebo-controlled, double-blind study. It comprised five parts, including single ascending dose, multiple ascending dose, and dose-response assessments. The study aimed to evaluate the safety, tolerability, pharmacokinetics, and proof-of-concept of subcutaneous amycretin in individuals with overweight or obesity. The proof-of-concept portion explored body weight loss over 36 weeks with escalating doses of 1.25 mg, 5 mg, and 20 mg, administered for 12 weeks each.
Future Directions
Based on these promising results, Novo Nordisk is planning further clinical development of amycretin in adults with overweight or obesity. The company aims to explore amycretin's potential as a treatment for both overweight/obesity and type 2 diabetes, with ongoing development of both oral and subcutaneous formulations.
