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Shares of Novo Nordisk NVO gained 8.5% on Friday after the company announced positive top-line data from an early to mid-stage study of its investigational candidate, amycretin, in 125 overweight/obese patients. Amycretin is NVO’s unimolecular GLP-1 and amylin receptor agonist intended for once-weekly subcutaneous administration.
The phase Ib/IIa study evaluated the safety, tolerability, pharmacokinetics and proof-of-concept of three doses of amycretin in obesity patients for a total treatment duration of up to 36 weeks.
Per Novo Nordisk, the study's primary safety endpoint was met as amycretin demonstrated a safety profile consistent with incretin-based therapies. Treatment-related adverse events were mostly mild to moderate in severity.
NVO shares have plunged 21.7% in the past three months compared with the industry’s 12.2% decline.
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Detailed Results From the Obesity Study of NVO’s Amycretin
Analysis of the study data, assuming all people adhered to treatment, revealed that patients starting with a mean baseline weight of 92.7 kg experienced an estimated weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22% on 20mg (36 weeks) of amycretin compared with a gain in body weight of approximately 1.9%, 2.3% and 2.0% in patients treated with placebo, respectively.
Based on such encouraging results, the company is currently planning further clinical development of the candidate in adults with overweight or obesity.
We would like to remind the investors that in 2024, Novo Nordisk announced that an oral formulation of amycretin showed faster weight loss than its blockbuster weekly injection for chronic weight management, Wegovy (semaglutide), in a phase I study.
Per the data, patients receiving the highest dose of amycretin experienced a 13.1% reduction in body weight after 12 weeks, while those receiving the low dose lost around 10.4%. In stark contrast, Wegovy only showed a weight loss of around 6% after 12 weeks and around 15% after 68 weeks in clinical studies.
Amycretin outperformed Wegovy due to the differences in the mechanisms of action of the drugs. Wegovy contains semaglutide, which only targets a hormone called GLP-1 to trigger weight loss. However, amycretin targets GLP-1, as well as a second hormone called amylin. Notably, amylin originates in the pancreas and is responsible for reducing food intake by delaying stomach emptying and decreasing blood glucose levels, leading to the reduction of body weight.
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