Semaglutide 7.2 mg Achieves Weight Reduction of 21% in Late-Stage STEP UP Trial
The 20.7% weight loss with the high-dose of semaglutide bested the mean reduction of 17.5% seen with semaglutide 2.4 mg, according to Novo Nordisk.
Novo Nordisk announced today promising findings from the late-stage STEP UP clinical trial demonstrating that a high-dose (7.2 mg) formulation of semaglutide achieved a mean weight loss of 20.7% after 72 weeks when adhering to the treatment protocol, compared to 17.5% with semaglutide 2.4 mg and 2.4% with placebo. Based on the treatment policy estimand, which accounts for treatment effect regardless of adherence, the 7.2 mg dose led to an average weight loss of 18.7%, surpassing the 15.6% achieved with the 2.4 mg dose and 3.9% with placebo1
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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.
The phase 3b trial enrolled 1,407 adults with a baseline body weight of 113 kg (approximately 249 lbs) and a body mass index (BMI) of 30 kg/m² or greater and without diabetes. All participants received weekly subcutaneous injections alongside lifestyle interventions, which included diet and exercise recommendations.1
“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,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in a company statement. He also noted the broader health benefits of semaglutide, such as cardiovascular risk reduction, as observed in the SELECT trial.
Adverse events in the STEP UP trial were consistent with the known profile of GLP-1 receptor agonists. The most common side effects were gastrointestinal in nature, typically mild to moderate in severity, and decreased over time.
STEP UP was a 72-week randomized, double-blind, placebo-controlled superiority trial designed to evaluate the weight loss potential of semaglutide 7.2 mg compared with the 2.4-mg dose and placebo as treatment in conjunction with lifestyle change. The primary outcome of interest was semaglutide 7.2 mg superiority. The secondary endpoints, now common in trials of antiobesity medications, were the number of participants who reached weight loss of 10%, 15%, 20%, and 25%.
A second phase 3 study, STEP UP T2D, will enroll 512 adults with obesity and type 2 diabetes. The primary outcome of interest is superiority of semaglutide 7.2 mg vs placebo for weight loss. Results from this companion study are expected in the coming months.
Semaglutide 2.4 mg, a glucagon-like peptide 1 receptor agonist marketed as Wegovy, is approved in the US and European Union, indicated for weight management in adults whose BMI is 30 kg/m2 or greater (obesity) or who have a BMI of 27 kg/m2 or greater (overweight) and at least 1 comorbidity related to excess weight. The medication is to be used alongside reduced caloric intake and an increase in physical activity. Used in this adjunctive role, semaglutide is indicated in the US to reduce the risk of major adverse cardiovascular (CV) events in adults with CV disease and obesity or overweight. cardio
Detailed results from STEP UP are expected to be presented at an upcoming scientific conference in 2025.
In 2024, nearly half (40%) of US adults met the criteria for obesity and nearly 1 in 10 for severe obesity. A sobering estimate for 2024 suggests that nearly 1 in 5, or 20% of children aged 2 to 19, had obesity.2 The chronic, relapsing disease increases the risk for hypertension, T2D, coronary heart disease, stroke, and certain cancers.2 Traditional weight-loss interventions often yield modest results, making pharmacologic options like semaglutide increasingly important, the company stated.1
