Liraglutide, marketed as Saxenda by Novo Nordisk, has demonstrated efficacy in reducing body mass index (BMI) in children aged 6 to 11 with obesity, according to results from a Phase III clinical trial. The findings, presented at the European Association for the Study of Diabetes (EASD) annual meeting in Madrid and published in the New England Journal of Medicine, suggest that liraglutide could become the first approved pharmacological treatment for general obesity in this young age group.
Study Details
The randomized, placebo-controlled trial, known as SCALE Kids, enrolled 82 children aged 6 to 12 years with obesity. Participants were randomized to receive either a daily injection of liraglutide or a placebo, in addition to lifestyle counseling focused on healthy eating and physical activity. The primary endpoint was the change in BMI after 52 weeks.
The results showed that children in the liraglutide group experienced a mean BMI reduction of 5.8%, compared to a 1.6% increase in the placebo group (p<0.05). Furthermore, 46% of participants in the liraglutide group achieved at least a 5% reduction in BMI, compared to only 9% in the placebo group. According to Dr. Claudia Fox, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota and lead author of the study, a 5% reduction in BMI has previously been associated with improvements in some obesity-related health conditions.
Safety and Tolerability
While liraglutide was generally well-tolerated, gastrointestinal side effects such as nausea, vomiting, and diarrhea were more common in the liraglutide group. However, these side effects were typically mild to moderate and rarely led to discontinuation of the study. It is important to note that when children stopped using the medication, their BMI tended to increase again, highlighting the need for long-term management strategies.
Implications for Clinical Practice
"Obesity is the most common chronic disease of childhood," Dr. Fox noted. "Left untreated, obesity in childhood almost universally persists into adulthood and is associated with significant ill health, including diabetes and cardiovascular disease, and for some, premature death. Early intervention is therefore critical."
The current treatment landscape for childhood obesity primarily relies on lifestyle interventions, including diet and exercise. However, these approaches often have limited success, and there are currently no approved medications for treating general obesity in children under 12. Liraglutide, a GLP-1 receptor agonist, mimics the action of a hormone called GLP-1 to reduce appetite and feelings of hunger, slow the release of food from the stomach and increase feelings of fullness after eating.
Novo Nordisk plans to submit these data to regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approval to expand the label for Saxenda to include children aged 6 to 11. If approved, liraglutide could provide a valuable new tool for addressing the growing epidemic of childhood obesity.
Expert Commentary
Dr. Nerys Astbury, an associate professor of diet and obesity at the Nuffield Department of Primary Health Care Sciences at the University of Oxford, emphasized the potential long-lasting health benefits of treating children and adolescents living with obesity. She noted that while these medications are currently costly, their value for reducing the risk of obesity-associated conditions and improving longer-term health must be considered.
However, some experts have raised concerns about the potential long-term effects of appetite suppression on growth and development in young children. Dr. Simon Cork, a senior lecturer in physiology at Anglia Ruskin University in England, cautioned that further studies over longer time periods are needed to ensure that appetite suppression in these children does not have unforeseen negative consequences later in their development.
Novo Nordisk's Broader Obesity Portfolio
Novo Nordisk has been a dominant player in the obesity market with its GLP-1 receptor agonists, including Wegovy (semaglutide) and Saxenda (liraglutide). The company is also developing CagriSema (cagrilintide/semaglutide), a fixed-dose combination of cagrilintide and semaglutide, which is being evaluated across the cardiometabolic spectrum, including heart failure and MASH (metabolic associated steatohepatitis).
