Novo Nordisk phase 2 trial with amycretin reports significant weight loss and HbA1c reduction in type 2 diabetes

Core Insights - Novo Nordisk announced positive results from a phase 2 clinical trial of amycretin for type 2 diabetes, highlighting its commitment to innovation in diabetes treatment [1][8][9] Trial Overview - The trial involved 448 participants with type 2 diabetes inadequately controlled on metformin, with or without SGLT2 inhibitors, and assessed the efficacy, safety, and pharmacokinetics of once-weekly subcutaneous and once-daily oral amycretin [2][12] - The study included multiple ascending doses, with six subcutaneous doses ranging from 0.4 mg to 40 mg and three oral doses of 6 mg, 25 mg, and 50 mg, over a treatment duration of up to 36 weeks [2][12] Efficacy Results - Subcutaneous amycretin achieved a maximum HbA1c reduction of -1.8% from a baseline of 7.8%, with 89.1% of participants reaching HbA1c <7% and 76.2% achieving ≤6.5% [3][11] - Oral amycretin resulted in a maximum HbA1c reduction of -1.5% from a baseline of 8.0%, with 77.6% achieving HbA1c <7% and 62.6% achieving ≤6.5% [4][11] - Placebo groups showed minimal improvements in HbA1c, confirming the statistical significance of amycretin's efficacy [5] Weight Loss Outcomes - Subcutaneous amycretin led to a statistically significant weight loss of up to -14.5% from a baseline weight of 99.2 kg, compared to -2.6% in the placebo group [6][11] - Oral amycretin resulted in a weight loss of up to -10.1% from a baseline weight of 101.1 kg, also significantly better than the placebo [6][11] Safety Profile - Both subcutaneous and oral amycretin demonstrated a safe and well-tolerated profile, with gastrointestinal issues being the most common adverse events, primarily mild to moderate in severity [7][11] Future Development Plans - Based on the positive phase 2 results, Novo Nordisk plans to initiate a phase 3 development program for amycretin targeting adults with type 2 diabetes in 2026 [9][10]