Saxenda was approved by the US Food and Drug Administration (FDA) for obesity management for adolescents aged 12 years and older, in 2020. Image credit: Kittyfly / Shutterstock.

Novo Nordisk showcased the efficacy of its obesity therapy, Saxenda (liraglutide), in children under 12 years of age with positive Phase III trial data.

The participants in the Saxenda group saw a mean body mass index (BMI) reduction of 5.8%, compared to 1.6% in the placebo group. The Phase III trial data was presented at the European Association for the Study of Diabetes (EASD) taking place from 9-13 September in Spain. The results were also published in the New England Journal of Medicine.

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Novo Nordisk has dominated the obesity space with Wegovy (semaglutide) and Saxenda. The drugs raked in combined global sales of DKr41.6bn ($6bn) last year, per the company’s financials. However, the company has been feeling the effects of increased competition from the likes of Eli Lilly’s GLP-1 Zepbound (tirzepatide) and supply chain constraints. Novo Nordisk reported “lower-than-expected” sales for Wegovy in Q2 this year.

The randomised placebo-controlled Phase III SCALE Kids trial (NCT04775082) enrolled 82 children aged 6 to12 years with obesity. At 52 weeks, the trial met its primary endpoint by demonstrating a 5.8% mean reduction in BMI with Saxenda. At least a 5% reduction in BMI was observed in 46% of participants in the Saxenda group, compared to 9% of participants in the placebo group.

The incidence of adverse events was comparable in both groups, 89% and 88% of participants in the liraglutide and placebo groups, respectively.

Saxenda has been approved by the US Food and Drug Administration (FDA) for obesity management for adolescents as young as 12 years. Novo Nordisk plans to use the Phase III SCALE Kids trial data to expand the Saxenda label to include obese children older than 6 years.

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Novo Nordisk has also made advances in expanding the use of its obesity products to cardiovascular indications. In March, the company’s blockbuster drug Wegovy was approved by the FDA for reducing the risk of cardiovascular diseases in obese or overweight adults.

The company also plans to expand its obesity portfolio with CagriSema (cagrilintide/semaglutide), a fixed dose combination of cagrilintide, a dual amylin and calcitonin receptor agonist and semaglutide, a glucagon-like peptide 1 (GLP-1) agonist. In May, the company shared plans to potentially evaluate the therapy across the cardiometabolic spectrum, such as heart failure, MASH (metabolic associated steatohepatitis), and even obstructive sleep apnoea.