Novo Nordisk has presented findings from the phase 3b STEP UP trial at the American Diabetes Association (ADA) Scientific Sessions in Chicago. The study revealed that a higher dose of Wegovy (semaglutide 7.2 mg) resulted in an average weight loss of 21% among individuals with obesity, with one-third achieving a weight reduction of 25% or more compared to placebo over a period of 72 weeks.
“The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide’s established safety profile. This may offer another option to people who do not attain their weight goals,” said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, Canada.
The safety profile for the higher dose was consistent with previous trials involving semaglutide. Most adverse events were gastrointestinal and were generally mild to moderate during dose escalation.
Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk, commented on the results: “With these results, semaglutide reaffirms its significant weight loss for people with obesity. The STEP UP trial delivers a substantial weight loss of over 20%, in addition to health benefits previously demonstrated with semaglutide.”
Novo Nordisk plans to seek regulatory approval for this higher dosage in Europe later this year, followed by submissions in other markets where Wegovy is already approved.
The STEP UP trial was conducted as a randomised, double-blinded study involving 1,407 adults without diabetes but with obesity. A parallel study called STEP UP T2D involved participants with type 2 diabetes.
Wegovy is marketed under the brand name Wegovy and is used as an adjunct therapy for weight management in adults and certain pediatric patients meeting specific criteria related to BMI and comorbid conditions.
Novo Nordisk is a global healthcare company based in Denmark focused on chronic diseases such as diabetes. The company employs approximately 77,400 people across various countries worldwide.
