DENMARK—Danish pharmaceutical giant Novo Nordisk has announced promising results from a phase 1b/2a clinical trial evaluating amycretin, a novel once-weekly injectable drug designed for weight management and type 2 diabetes treatment.
Amycretin is a long-acting dual agonist that targets both the GLP-1 and amylin receptors, aiming to provide an effective and convenient treatment option for adults struggling with overweight or obesity.
Novo Nordisk is developing the drug in both oral and injectable forms.
These latest findings come just weeks after the company released positive phase 3b results from the STEP UP trial, part of its global STEP program, which evaluates Wegovy, another obesity treatment.
The phase 1b/2a study on amycretin assessed its safety, tolerability, pharmacokinetics, and initial weight-loss effects in 125 participants with overweight or obesity.
The trial included single and multiple ascending doses, as well as a dose-response analysis, with participants receiving treatment for up to 36 weeks.
Results showed that amycretin had a safety profile consistent with other incretin-based therapies. The most common side effects were gastrointestinal issues, which were mostly mild to moderate.
Results showed promising weight-loss outcomes, with people receiving amycretin lost an estimated 9.7% of their body weight on the 1.25 mg dose (over 20 weeks), 16.2% on the 5 mg dose (over 28 weeks), and 22.0% on the 20 mg dose (over 36 weeks).
In contrast, those receiving a placebo experienced slight weight gain of 1.9%, 2.3%, and 2.0%, respectively.
Regarding safety, the trial’s primary endpoint was the occurrence of treatment-related side effects.
Amycretin’s safety profile was consistent with that of other incretin-based therapies.
The most common side effects were mild to moderate gastrointestinal issues.
This announcement comes just weeks after Novo Nordisk shared positive findings from STEP UP, a phase 3b clinical trial under its global STEP program, which focuses on developing effective obesity treatments.
Commenting on the findings, Martin Lange, executive vice president for Development at Novo Nordisk, expressed optimism about amycretin’s potential.
He stated that the subcutaneous trial results reinforce the drug’s ability to support weight loss, an effect also observed in its oral formulation.
Following these encouraging results, Novo Nordisk now plans to advance amycretin into further clinical trials to evaluate its effectiveness in a larger patient population.
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