Shares of Novo Nordisk NVO were up 4.7% yesterday, after the company announced positive data from a phase II study evaluating its investigational pipeline candidate, amycretin, in people with type 2 diabetes.
The study evaluated the safety, efficacy and pharmacokinetics of once-weekly subcutaneous amycretin and once-daily oral amycretin versus placebo in people with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor as standard of care.
Amycretin is a novel, unimolecular co-agonist of both GLP-1 and amylin receptors being developed by Novo Nordisk to provide an efficacious and convenient treatment for obesity and type 2 diabetes in adults.
Year to date, shares of Novo Nordisk have declined 45.3% against the industry’s rally of 15.9%.
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The phase II study was a combined multiple ascending dose study, which evaluated six weekly injected doses of amycretin from 0.4 mg to 40 mg and three daily oral doses of 6 mg, 25 mg, and 50 mg. Participants were treated for up to 36 weeks.
From a mean baseline body weight of 99.2 kg, patients receiving subcutaneous amycretin achieved statistically significant weight loss of up to 14.5% compared to 2.6% in people treated with placebo. Likewise, from a mean baseline body weight of 101.1 kg, patients taking oral amycretin achieved statistically significant weight loss of up to 10.1% compared to 2.5% in the placebo group.
The data also showed that people who stayed on treatment, with an average starting HbA1c blood sugar level of 7.8%, once-weekly subcutaneous amycretin lowered HbA1c by up to 1.8% by week 36. Up to 89.1% of patients reached HbA1c levels below 7%, and up to 76.2% achieved levels at or below 6.5%.
Meanwhile, starting from an average HbA1c level of 8.0%, people taking once-daily oral amycretin achieved dose-dependent reductions of up to 1.5% by week 36. With oral treatment, 77.6% of patients reached HbA1c levels below 7% and 62.6% reached levels at or below 6.5%.
In comparison, patients receiving placebo saw much smaller HbA1c reductions — only 0.2% in the subcutaneous group and 0.4% in the oral group.
In the phase II study, both the injectable and oral forms of amycretin were generally safe and well-tolerated, with side effects similar to those seen with other incretin and amylin-based treatments.
Based on these data, the phase III program on amycretin for adults with type 2 diabetes is planned to be initiated in 2026.
In September 2024, NVO announced that oral amycretin showed faster weight loss than its blockbuster weekly injection for chronic weight management, Wegovy (semaglutide), in the phase I study.
