Novo Nordisk has reported topline outcomes from a Phase Ib/IIa trial of amycretin designed for treating obese or overweight individuals.
The trial assessed the safety, pharmacokinetics, efficacy, proof-of-concept and tolerability of the unimolecular glucagon-like peptide 1 (GLP-1) and amylin receptor agonist.
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The single ascending dose, multiple ascending dose, and dose-response study explored three distinct maintenance doses of one-time-a-week subcutaneous administration of the therapy over a 36-week period.
According to the findings, amycretin’s safety profile aligns with that of other incretin-based therapies, and treatment-emergent adverse events were the primary endpoint.
Subjects receiving the therapy experienced notable weight loss, with an estimated reduction of 9.7% on 1.25mg over 20 weeks, 16.2% on 5mg over 28 weeks, and 22% on 20mg over a 36-week period.
In contrast, those on a placebo saw an estimated body weight gain.
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By GlobalDataNovo Nordisk Development executive vice-president Martin Lange said: “We are very encouraged by the subcutaneous Phase Ib/IIa results for amycretin in people living with overweight or obesity.
“The results seen in the trial support the weight lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist, amycretin, that we have previously seen with the oral formulation.”
With this latest announcement, the shares of the company were 7.13% higher, reported CNBC.
A further clinical development of the therapy for obese or overweight adults is being planned by the company, based on the trial outcomes.
Amycretin is also being developed for the treatment of type 2 diabetes in this particular patient group and is formulated for both oral and subcutaneous administration.
Prior to this trial, the company reported improved weight loss outcomes with a high dose of Wegovy in the Phase IIIb STEP UP trial.
