Novo Nordisk Reports Positive Phase 1b/2a Results for Amycretin

Novo Nordisk, a prominent global healthcare firm, reported topline outcomes from a phase 1b/2a clinical trial involving amycretin, a unimolecular GLP-1 and amylin receptor agonist designed for weekly subcutaneous administration. The study evaluated the safety, tolerability, pharmacokinetics, and proof-of-concept following once-weekly subcutaneous injections of amycretin in 125 individuals with overweight or obesity. The study was a combined single ascending dose, multiple ascending dose, and dose-response trial examining three distinct maintenance doses over a total treatment period of up to 36 weeks.

The main objective was adverse events that emerged during treatment. The safety characteristics of amycretin were in line with those of incretin-based treatments. The most frequent side effects associated with amycretin were gastrointestinal, and most were mild to moderate in intensity.

When assessing the impact of treatment assuming all individuals followed the regimen from a mean baseline weight of 92.7 kg, those receiving amycretin experienced an estimated weight reduction of 9.7% at 1.25mg (20 weeks), 16.2% at 5mg (28 weeks), and 22.0% at 20mg (36 weeks). Individuals given a placebo showed an approximate body weight increase of 1.9%, 2.3%, and 2.0%, respectively.

“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. “The results seen in the trial support the weight lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist, amycretin, that we have previously seen with the oral formulation."