Novo Nordisk A/S phase 2 trial with amycretin reports significant weight loss and HbA1c reduction in type 2 diabetes (44.97)
- Co announced positive headline results from a phase 2 clinical trial with amycretin in people with type 2 diabetes. This marks the first evaluation of amycretin in people with type 2 diabetes, further demonstrating Novo Nordisk's commitment to advancing innovation in the treatment of type 2 diabetes. Amycretin is a unimolecular agonist of the glucagon-like peptide 1 (GLP-1) and amylin receptors, intended for once-weekly subcutaneous administration and once-daily oral administration.
- The trial investigated the efficacy, safety and pharmacokinetics of once-weekly subcutaneous amycretin and once-daily oral amycretin compared to placebo in 448 people with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor as standard of care. Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial. The trial was a combined multiple ascending dose study, investigating six subcutaneous doses from 0.4 mg to 40 mg administered weekly, and three daily oral doses of 6 mg, 25 mg and 50 mg, with a total treatment duration of up to 36 weeks.
- When evaluating the effects of treatment, if all people adhered to treatment1 from a mean baseline HbA1c of 7.8%, once-weekly subcutaneous amycretin achieved dose-dependent reductions in HbA1c of up to -1.8% by week 36. The proportion of people achieving HbA1c <7% and =6.5% was up to 89.1% and 76.2% respectively.
- From a mean baseline HbA1c of 8.0%, people treated with once-daily oral amycretin achieved dose-dependent improvements in HbA1c of up to -1.5% by week 36. The proportion of people achieving an HbA1c level of <7% and =6.5% with once-daily oral amycretin was 77.6% and 62.6% respectively.
- By comparison, people treated with placebo achieved HbA1c improvement of -0.2% and -0.4% with subcutaneous and oral amycretin, respectively. The estimated improvements in HbA1c were all statistically significant versus placebo, confirming the primary endpoints of the trial.
- From a mean baseline body weight of 99.2 kg, subcutaneous amycretin achieved statistically significant weight loss of up to -14.5% compared to -2.6% in people treated with placebo. People treated with the highest dose of subcutaneous amycretin were on the final maintenance dose for a duration of 4 weeks. Similarly, from a mean baseline body weight of 101.1 kg, people treated with oral amycretin also achieved statistically significant weight loss of up to -10.1% compared to -2.5% in people treated with placebo. For the higher doses of amycretin, irrespective of administration route, no weight loss plateau was observed at week 36.
- Based on the results, Novo Nordisk is now planning to initiate a phase 3 development programme with amycretin for adults with type 2 diabetes in 2026.