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STEP UP: Semaglutide 7.2mg achieves 20.7% weight loss and 18.7% regardless of treatment adherence

owenhaskins

Novo Nordisk has announced headline results from the STEP UP study, a phase 3b trial in the global STEP programme, which revealed the trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 72 with semaglutide 7.2mg versus placebo.


STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2mg compared to semaglutide 2.4mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle intervention.



When evaluating the effects of treatment if all people adhered to treatment from a mean baseline body weight of 113kg, people treated with 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. In addition, 33.2% of those who received semaglutide 7.2mg achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with semaglutide 2.4mg and 0.0% with placebo.

When applying the treatment policy estimand, people treated with semaglutide 7.2mg achieved a superior weight loss of 18.7% compared to a reduction of 15.6% with semaglutide 2.4mg and 3.9% with placebo.


In the trial, semaglutide 7.2mg 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 7.2mg, with a safety and tolerability profile comparable to semaglutide 2.4mg,” 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 7.2mg phase 3 trial, STEP UP T2D, in adults with type 2 diabetes and obesity are expected within the next few months.


The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy of semaglutide 7.2mg with semaglutide 2.4mg and placebo as an adjunct to lifestyle intervention. 1,407 adults with BMI ≥30kg/m2 and without diabetes were included in the trial. The primary objective was to demonstrate superiority of semaglutide 7.2mg against placebo on weight loss. Key secondary endpoints included number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively.


The ongoing 72-week STEP UP T2D trial will investigate semaglutide 7.2mg in 512 adults with obesity and type 2 diabetes, with the primary objective to demonstrate superiority of semaglutide 7.2mg against placebo on weight loss.


Detailed results from the STEP UP trial are expected to be presented at a scientific conference in 2025.

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