- Phase 2 trial involved 448 participants with type 2 diabetes.
- Amycretin tested in doses from 0.4 mg to 50 mg over 36 weeks.
- Subcutaneous amycretin reduced HbA1c by up to 1.8% and body weight by 14.5%.
- Phase 3 development for amycretin to start in 2026.
Trial Overview
Novo Nordisk conducted a phase 2 trial to evaluate amycretin in 448 participants with type 2 diabetes inadequately controlled on metformin, with or without an SGLT2 inhibitor. The trial assessed the efficacy, safety, and pharmacokinetics of once-weekly subcutaneous and once-daily oral amycretin over 36 weeks.
Dosage and Results
The study tested six subcutaneous doses ranging from 0.4 mg to 40 mg and three oral doses of 6 mg, 25 mg, and 50 mg. Subcutaneous amycretin achieved dose-dependent HbA1c reductions of up to 1.8% and weight loss of up to 14.5%. Oral amycretin showed HbA1c reductions of up to 1.5% and weight loss of up to 10.1%.
Comparative Analysis
Participants on placebo experienced HbA1c improvements of 0.2% and 0.4% for subcutaneous and oral administration, respectively. The improvements with amycretin were statistically significant compared to placebo, confirming the trial's primary endpoints.
Safety Profile
Amycretin demonstrated a safe and well-tolerated profile, consistent with other incretin and amylin-based therapies. The most common adverse events were gastrointestinal, mostly mild to moderate in severity.
Future Plans
Based on these results, Novo Nordisk plans to initiate a phase 3 development program for amycretin in adults with type 2 diabetes in 2026.
