DENMARK – Danish pharmaceutical giant Novo Nordisk has released positive findings from STEP UP, a phase 3b clinical trial within its global STEP program.
STEP UP is a 72-week study that evaluated the efficacy and safety of a higher dose of semaglutide (7.2 mg) compared to the standard dose (2.4 mg) and a placebo.
All treatments were administered once weekly alongside lifestyle interventions. The trial involved 1,407 adults with obesity.
The study’s primary goal was to measure weight loss after 72 weeks.
The results showed that participants taking semaglutide 7.2 mg achieved a significantly greater weight loss than those on the lower dose or placebo.
On average, individuals receiving the higher dose reduced their body weight by 20.7% from a baseline of 113 kg, compared to 17.5% for those on 2.4 mg and 2.4% for the placebo group.
Remarkably, 33.2% of participants on the 7.2 mg dose lost at least 25% of their body weight, compared to 16.7% for the lower dose and none for the placebo group.
When considering the treatment policy estimand, which includes all participants regardless of adherence, the weight loss was slightly lower but still significant: 18.7% for 7.2 mg, 15.6% for 2.4 mg, and 3.9% for placebo.
The safety profile of semaglutide 7.2 mg was consistent with its drug class, GLP-1 receptor agonists. Most side effects were gastrointestinal, mild to moderate, and diminished over time.
Martin Holst Lange, Novo Nordisk’s executive vice president for Development, expressed his satisfaction with the results, emphasizing the superior weight loss achieved and the manageable safety profile.
He noted that the findings further enhance semaglutide’s clinical reputation for obesity treatment, complementing the benefits already demonstrated by Wegovy®, such as cardiovascular risk reduction shown in the SELECT trial.
Novo Nordisk plans to release results from another Phase 3 trial, STEP UP T2D, which examines semaglutide 7.2 mg in adults with obesity and type 2 diabetes.
These findings are expected in the coming months, with detailed data from the STEP UP trial set to be presented at a scientific conference in 2025.
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