(Health Korea News / Yu Ji-in) Novo Nordisk’s Saxenda (ingredient name: Liraglutide) was found to be effective in treating obesity in children aged 6 to 12.
Novo Nordisk announced the results of a phase 3 clinical trial (NCT04775082) containing these contents at the European Association for the Study of Diabetes (EASD) held in Spain from September 9 to 13. The results of the study were published in the New England Journal of Medicine.
In a phase 3 clinical trial conducted on 82 obese children aged 6 to 12, the Saxenda group showed an average 5.8% decrease in BMI at week 52. The placebo group showed a decrease of only 1.6%. The number of cases where BMI values decreased by at least 5% was 46% in the Saxenda group and 9% in the placebo group.
The incidence of side effects was similar in both groups, occurring in 89% and 88% of participants in the Saxenda group and the placebo group, respectively. Liraglutide has been shown to be safe in children. The results of this clinical trial also confirmed that Saxenda caused mild side effects. Most of them were gastrointestinal side effects such as nausea, diarrhea, and vomiting, and were temporary reactions.
Saxenda was approved by the U.S. Food and Drug Administration (FDA) in 2014 and 2020 to treat obesity in adults and adolescents, respectively. However, no treatment has yet been approved to treat obesity in children under 12 years of age. Novo Nordisk said it plans to use the data from this phase 3 trial to expand Saxenda’s label to obese children 6 years of age and older.
Novo Nordisk has made progress in expanding the use of its obesity product to cardiovascular indications. In March, the company’s blockbuster drug Wegovy (semaglutide) won FDA approval to reduce the risk of cardiovascular disease in obese or overweight adults.
The company said it plans to “expand its obesity portfolio with Cagrisema (active ingredient: capriglintide/semaglutide), a fixed-dose combination of capriglintide, a dual amylin and calcitonin receptor agonist, and semaglutide, a glucagon-like peptide 1 (GLP-1) agonist.”
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