Novo Nordisk's older weight-loss drug, Saxenda (liraglutide), helped children between the ages of 6 and 11 reduce their body mass index (BMI) by an average of 7.4% in a 56-week trial. This study was the first to evaluate the safety and efficacy of daily Saxenda injections in young children. Currently, no medications are approved for obesity treatment in children under 12, although Saxenda is approved for adolescents and adults. Novo Nordisk has applied to U.S. and European regulators for expanded approval to include this younger age group. If approved, Saxenda would be the first drug authorized to treat obesity in children aged 6 through 11, a condition affecting over 20% of U.S. children in this demographic.
The trial, which included 82 participants (56 in the liraglutide group and 26 in the placebo group), met its primary endpoint of BMI reduction and secondary endpoints, including weight loss. While effective, side effects were common, particularly gastrointestinal issues such as nausea, vomiting, and diarrhea, occurring in 80% of the liraglutide group compared to 54% in the placebo group. Serious adverse events were reported in 12% of the liraglutide group and 8% of the placebo group. Experts emphasize the need for careful consideration of these risks and the lack of long-term data on such drugs in young children.
Liraglutide belongs to the GLP-1 class of drugs, which includes other blockbuster medications like Wegovy and Ozempic (semaglutide) and Mounjaro (tirzepatide). These medications mimic hormones that regulate appetite and fullness. While effective, these drugs are typically intended for lifelong use. Concerns exist among medical professionals, such as Dr. Roy Kim, a pediatric endocrinologist at Cleveland Clinic Children’s, regarding the potential long-term impacts on children's growth, bone health, and possible risks like pancreatic problems or thyroid cancer, especially given the crucial developmental stage of children aged 6 to 11. Despite the "relatively small" weight loss and the limited study size, the results are seen as a promising indicator of future treatments for childhood obesity.
