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Novo Nordisk's high dose Wegovy (semaglutide) has shown improved weight loss while remaining safe and tolerable.
In the Phase IIIb STEP UP trial, 7.2mg Wegovy demonstrated statistically significant and superior weight loss abilities at week 72. In the trial, 1,407 obese adult subjects were randomised to receive once-weekly treatments, supplemented by lifestyle interventions.
From a mean baseline body weight of 113kg, subjects who received high dose Wegovy experienced weight loss of 20.7% over the trial period. This was significantly higher than the reduction achieved with standard dose Wegovy, 2.4mg, and the placebo, which resulted in losses of 17.5% and 2.4%, respectively.
In addition, 33.2% of subjects receiving the therapy achieved 25% or more weight loss post-72 weeks.
This outcome was significantly greater than the 16.7% observed in the 2.4mg group and the 0.0% in the placebo group.
Applying the treatment policy estimand, which accounts for factors such as adherence, the higher dose of Wegovy led to a weight loss of 18.7%, surpassing the 15.6% achieved with the standard dose and the 3.9% with the placebo.
The 7.2mg dose was also reported to have a safe and well-tolerated profile, the company noted.
Wegovy was approved as a 2.4mg dose by the US Food and Drug Administration (FDA) in June 2021 and in the EU in January 2022.
Novo Nordisk development executive vice-president Martin Holst Lange said: “Results from STEP UP further strengthen the clinical profile of semaglutide for the treatment of obesity, in addition to the health benefits already established with Wegovy, including cardiovascular risk reduction, as seen in SELECT.”
The STEP UP and STEP UP T2D trials are important for the company’s exploration into the efficacy of Wegovy 7.2mg.
Further insights are anticipated from the STEP UP T2D trial evaluating the therapy in adults with type 2 diabetes and obesity, and results are expected in the following months.
In May 2023, the company reported positive outcomes from its OASIS 1 Phase IIIa trial of oral semaglutide 50mg, which achieved its primary endpoint of improved weight loss at week 68 in obese or overweight adults.
"Novo Nordisk’s high-dose Wegovy increases weight loss and remains safe" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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