Novo Nordisk A/S (NYSE:NVO) on Tuesday released headline results from a phase 2 trial with amycretin for type 2 diabetes.
The update marks the first evaluation of amycretin in people with type 2 diabetes.
Novo Nordisk is planning to initiate a phase 3 development program with amycretin for adults with type 2 diabetes in 2026. In June, the company said it planned to initiate a phase 3 development for amycretin for adults with overweight or obesity in the first quarter of 2026.
The trial evaluated once-weekly subcutaneous amycretin and once-daily oral amycretin compared with placebo in 448 patients 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.
SGLT2 inhibitors are a class of prescription medications used to treat type 2 diabetes by causing the kidneys to remove excess glucose from the body through urine.
The trial was a combined multiple-ascending-dose study investigating six subcutaneous doses ranging 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.
Also Read: Novo Nordisk’s Blockbuster Weight-Loss Drug Flops In Alzheimer’s Trial
When evaluating the effects of treatment, if everyone adhered to treatment from a mean baseline HbA1c (blood sugar level) of 7.8%, once-weekly subcutaneous amycretin achieved dose-dependent reductions in HbA1c of up to -1.8% by week 36.
The proportions of people achieving HbA1c <7% and ≤6.5% were 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 proportions of people achieving HbA1c levels of <7% and ≤6.5% with once-daily oral amycretin were 77.6% and 62.6%, respectively.
By comparison, people treated with a placebo achieved HbA1c improvement of -0.2% and -0.4% with subcutaneous and oral amycretin, respectively.
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 subcutaneous amycretin dose were on the final maintenance dose for 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 a placebo.
For the higher doses of amycretin, regardless of administration route, no weight-loss plateau was observed at week 36.
Price Action: NVO stock is up 2.16% at $45.92 during the premarket session at the last check on Tuesday.
Read Next:
Photo: Shutterstock
