Novo Nordisk's Semaglutide 7.2 mg Shows Promising Weight Loss Results in STEP UP Trial

Novo Nordisk Achieves Landmark Results in Obesity Treatment with Semaglutide 7.2 mg

Novo Nordisk has released the headline results from its STEP UP trial, a Phase 3b study assessing the efficacy and safety of subcutaneous semaglutide 7.2 mg in treating obesity. This pivotal trial, which is part of the global STEP programme, has revealed significant weight loss achievements, bolstering the clinical profile of semaglutide as a potential treatment for obesity.

Key Findings from the STEP UP Trial

The STEP UP trial, a 72-week efficacy and safety study, enrolled 1,407 adults with obesity. Participants were randomly assigned to receive either semaglutide 7.2 mg, semaglutide 2.4 mg, or placebo, all administered weekly alongside lifestyle intervention. The trial met its primary endpoint, demonstrating superior weight loss with semaglutide 7.2 mg compared to placebo.

20.7% Weight Loss Achieved with Semaglutide 7.2 mg: Those who adhered to the treatment regimen experienced a remarkable average weight loss of 20.7% over the 72-week period, compared to 17.5% with semaglutide 2.4 mg and just 2.4% with placebo.

25% Weight Loss in 33.2% of Patients: A third of patients receiving semaglutide 7.2 mg achieved a weight loss of 25% or more, underscoring the drug's potential for significant weight reduction.

18.7% Weight Loss with Treatment Policy Estimand: When considering all participants, regardless of treatment adherence, those receiving semaglutide 7.2 mg experienced an 18.7% weight loss, far surpassing the 15.6% achieved with semaglutide 2.4 mg and 3.9% with placebo.

Safety and Tolerability

Semaglutide 7.2 mg demonstrated a safe and well-tolerated profile, with the most common adverse events being mild to moderate gastrointestinal issues. These side effects generally decreased over time, consistent with the expected outcomes for GLP-1 receptor agonist therapies.

Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, expressed his satisfaction with the results: “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.”

Looking Ahead: The Future of Semaglutide 7.2 mg

The encouraging data from STEP UP significantly strengthens semaglutide’s role in treating obesity, alongside other established benefits like cardiovascular risk reduction seen with Wegovy® in the SELECT trial. The results from another phase III trial, STEP UP T2D, examining semaglutide 7.2 mg in adults with type 2 diabetes and obesity, are expected in the coming months.

Additionally, detailed results from the STEP UP trial are set to be presented at a major scientific conference in 2025, further advancing the global conversation on effective obesity treatments.

About the STEP UP Trials

The STEP UP trials, which include both the STEP UP and STEP UP T2D studies, are crucial in evaluating the broader potential of semaglutide 7.2 mg. STEP UP focused on weight loss in adults with obesity, while the ongoing STEP UP T2D trial investigates its effects in individuals with obesity and type 2 diabetes. These trials aim to reinforce semaglutide's role as a game-changer in obesity management.

Wegovy® (semaglutide 2.4 mg): Expanding Access to Weight Loss Treatment

Semaglutide 2.4 mg, marketed under the brand name Wegovy®, continues to show promise in both weight management and the reduction of major cardiovascular events (MACE). Available in various regions, Wegovy® is indicated for weight loss in adults with a BMI of 30 or greater, or those with a BMI of 27 or greater in the presence of at least one weight-related comorbid condition. The product has also been shown to provide benefits in reducing the risk of MACE, improving symptoms of heart failure with preserved ejection fraction (HFpEF), and alleviating knee osteoarthritis pain.