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Bagsværd, Denmark, 17 January 2025 – Novo Nordisk today announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle intervention.
The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 72 with semaglutide 7.2 mg versus placebo.
When evaluating the effects of treatment if all people adhered to treatment1 from a mean baseline body weight of 113 kg, people treated with semaglutide 7.2 mg achieved a superior weight loss of 20.7% after 72 weeks compared to a reduction of 17.5% with semaglutide 2.4 mg and 2.4% with placebo. In addition, 33.2% of those who received semaglutide 7.2 mg achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with semaglutide 2.4 mg and 0.0% with placebo.
When applying the treatment policy estimand2, people treated with semaglutide 7.2 mg achieved a superior weight loss of 18.7% compared to a reduction of 15.6% with semaglutide 2.4 mg and 3.9% with placebo.
In the trial, semaglutide 7.2 mg appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.
“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 7.2 mg, with a safety and tolerability profile comparable to semaglutide 2.4 mg,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “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 results from the second semaglutide 7.2 mg phase 3 trial, STEP UP T2D, in adults with type 2 diabetes and obesity are expected within the next few months.
Detailed results from the STEP UP trial are expected to be presented at a scientific conference in 2025.
About the STEP UP trials
Novo Nordisk has initiated two trials investigating the efficacy of semaglutide 7.2mg, STEP UP and STEP UP T2D.
The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy of semaglutide 7.2 mg with semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. 1,407 adults with BMI ≥30 kg/m2 and without diabetes were included in the trial. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. Key secondary endpoints included number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively.