Novo Flaunts Phase II Data for Dual GLP-1/Amylin Agonist Amycretin

Novo Nordisk has announced Phase II trial results for peptide drug amycretin, demonstrating 1.8% haemoglobin A1c reduction from 7.8% baseline, and 14.5% weight loss versus 2.6% in the placebo arm, in 448 patients with inadequately controlled type 2 diabetes (T2D) on metformin with or without SGLT2 inhibitors. The weekly subcutaneous and daily oral formulations showed dose-dependent efficacy, with 89.1% and 77.6% patients achieving HbA1c below 7% respectively, without weight-loss plateau observed at 36 weeks. The safety profile remained consistent with incretin- and amylin-based therapies, with predominantly mild-to-moderate gastrointestinal adverse events, supporting Phase III initiation planned for 2026.

The single-molecule agonist targets GLP-1 and amylin receptors, representing a novel mechanism combining glucose-dependent insulin secretion enhancement with satiety promotion and glucagon suppression. 40% of trial participants had prior SGLT2 inhibitor exposure, reflecting the real-world population, with the oral formulation achieving 1.5% HbA1c reduction and 10.1% weight loss from a 101.1-kilogram baseline. Chief scientific officer Martin Holst Lange highlighted the broad Phase III development plan across multiple indications, leveraging dual receptor engagement potential for synergistic metabolic benefits beyond current GLP-1 receptor mono agonists in T2D and obesity management.

According to PharmCube's NextBiopharm® database, Novo leads development efforts for molecules targeting both amylin and GLP-1, although most competitors' candidates feature three or more targets. Click here to request a free trial for NextBiopharm®.

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