Novo Nordisk has shared positive headline results from a late-stage study evaluating a higher dose of its GLP-1 receptor agonist semaglutide in adults with obesity.
The phase 3b STEP UP trial has been comparing the experimental 7.2mg dose of semaglutide to the standard 2.4mg dose of the drug and placebo, all given once weekly in conjunction with lifestyle intervention.
Semaglutide, marketed under brand names such as Wegovy and Ozempic, already holds approvals for a range of indications, including weight management, diabetes and cardiovascular risk reduction.
Among patients who adhered to treatment in STEP UP, those receiving semaglutide 7.2mg achieved a superior weight loss of 20.7% after 72 weeks compared to a reduction of 17.5% with semaglutide 2.4mg and 2.4% with placebo.
Additionally, 33.2% of those being treated with semaglutide 7.2mg achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with semaglutide 2.4 mg and 0% with placebo.
For the overall population regardless of treatment adherence, patients in the higher-dose semaglutide group achieved a weight loss of 18.7% compared to 15.6% with semaglutide 2.4mg and 3.9% with placebo.
The higher dose also appeared to have a safe and well-tolerated profile, Novo outlined.
Martin Holst Lange, executive vice president for development at Novo Nordisk, 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”.
Semaglutide 7.2mg is also currently being evaluated in the phase 3 STEP UP T2D trial in adults with obesity and type 2 diabetes, with results expected within the next few months.
The announcement comes less than three months after Novo shared promising results from a late-stage study of semaglutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), a progressive metabolic disease that affects the liver and is closely linked with obesity as well as conditions such as type 2 diabetes.
Novo said it expects to file for regulatory approvals of semaglutide in MASH in the US and EU in the first half of this year.