On Friday, Novo Nordisk A/S (NYSE:NVO) released topline results from a phase 1b/2a trial with amycretin intended for once-weekly subcutaneous administration.
The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept after once-weekly subcutaneous administrations of amycretin in 125 people with overweight or obesity.
The trial was a combined single ascending, multiple ascending, and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.
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The primary endpoint was the treatment of emergent adverse events. When evaluating the effects of treatment if all people adhered to treatment from a mean baseline body weight of 92.7 kg, people treated with amycretin achieved an estimated body weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22.0% on 20mg (36 weeks).
People treated with a placebo experienced an estimated 1.9%, 2.3%, and 2.0% body weight gain, respectively.
The safety profile of amycretin was consistent with incretin-based therapies.
The most common adverse events with amycretin were gastrointestinal, and the vast majority were mild to moderate in severity.
Based on the results, Novo Nordisk is planning further clinical development of amycretin in adults with overweight or obesity. Last week, Novo Nordisk released headline results from the STEP UP Phase 3b trial in the global STEP program.
When evaluating the effects of treatment if all people adhered to treatment from a mean baseline body weight of 113 kg, people treated with semaglutide 7.2 mg achieved a superior weight loss of 20.7% after 72 weeks compared to a reduction of 17.5% with semaglutide 2.4 mg and 2.4% with placebo.
Price Action: NVO stock is up 10.80% at $89.90 during the premarket session at last check Friday.
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