Novo Nordisk has announced that its Phase 3b STEP UP trial achieved its primary endpoint, demonstrating statistically significant and superior weight loss with semaglutide 7.2mg compared to placebo over 72 weeks.
The trial is part of the global STEP programme evaluating obesity treatments.
The 72-week, randomised, double-blind trial enrolled 1,407 adults with obesity. It compared semaglutide 7.2mg with semaglutide 2.4mg and placebo, alongside lifestyle interventions.
Participants receiving semaglutide 7.2mg achieved a mean weight loss of 20.7% from a baseline of 113kg, under the treatment adherence scenario. This was significantly higher than the 17.5% reduction with semaglutide 2.4mg and the 2.4% reduction with placebo.
The trial also demonstrated that 33.2% of participants on semaglutide 7.2mg achieved a weight reduction of 25% or more, compared to 16.7% on semaglutide 2.4mg and none in the placebo group.
When analysed under the treatment policy estimand approach, semaglutide 7.2mg led to an 18.7% weight loss, outperforming semaglutide 2.4mg (15.6%) and placebo (3.9%).
The STEP UP trial confirmed that semaglutide 7.2mg was well-tolerated, with gastrointestinal events being the most reported adverse effects. These were mostly mild to moderate and diminished over time, consistent with other GLP-1 receptor agonists.
Novo Nordisk development executive vice president Martin Holst Lange said: “We are very pleased to demonstrate 20.7% weight loss and to see that 33% of patients achieved more than 25% weight loss with semaglutide 7.2mg, with a safety and tolerability profile comparable to semaglutide 2.4mg.
“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”.
Novo Nordisk said that it is continuing its research with the STEP UP T2D trial, which is evaluating semaglutide 7.2mg in adults with type 2 diabetes and obesity. Results from this study are expected in the coming months.
Semaglutide 2.4mg, marketed as Wegovy, is already approved in the European Union (EU) and the US for managing obesity and weight-related comorbidities in adults and paediatric patients.
In the EU, Wegovy is indicated for individuals with a body mass index (BMI) of 30kg/m² or greater, or 27kg/m² or greater with comorbid conditions. In the US, it is also approved for reducing major adverse cardiovascular events (MACE) in adults with established cardiovascular disease.
In the UK, UK Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for semaglutide, authorising its use to reduce the risk of serious cardiovascular events in overweight or obese adults.
