Novo's Saxenda Lowers BMI in Children Safely: NEJM Study

A recent study published in The New England Journal of Medicine revealed that children aged six to 12 who took liraglutide for a little over a year showed a noteworthy reduction in body mass index (BMI) compared to those who received a placebo. The research, backed by Novo Nordisk, indicates that their weight-loss medication, Saxenda (liraglutide), can aid in weight management for young children when combined with lifestyle adjustments.

The Phase IIIa study involved 82 children who were administered either Saxenda or a placebo. After 56 weeks, it was observed that children in the Saxenda group experienced a modest increase in body weight by 1.6%, whereas those in the placebo group saw a 10% increase. The difference, amounting to a reduction of 8.4 percentage points in favor of Saxenda, was statistically significant, with a p-value of 0.001.

Focusing on the study's primary outcome, BMI, children treated with Saxenda saw an average decrease of 5.8%, while those on placebo experienced a 1.6% increase. This outcome also achieved statistical significance, with a p-value of less than 0.001.

Regarding safety, adverse events were found to be common but evenly distributed between the Saxenda and placebo groups. However, gastrointestinal issues were more prevalent in children receiving Saxenda. Serious side effects were reported in 12% of children on Saxenda and in 8% of those on placebo.

Dr. Claudia Fox from the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School, the study's lead author, emphasized the urgency of addressing childhood obesity, which she described as the most prevalent chronic disease in children. Fox pointed out that apart from lifestyle changes, there are limited treatment options available for young patients. She highlighted the importance of early intervention to prevent obesity from continuing into adulthood, which is often linked with severe health issues such as diabetes, cardiovascular disease, and premature death.

Liraglutide was initially approved by the FDA in 2014 for weight loss in adults, and its approval was expanded in 2020 to include children aged 12 to 17. Saxenda is part of the GLP-1 receptor agonists class of medications, which also includes Novo Nordisk’s popular semaglutide brands Ozempic and Wegovy, and Eli Lilly’s tirzepatide brands Mounjaro and Zepbound. These drugs are generally prescribed for type 2 diabetes or chronic weight management and function by reducing appetite, slowing stomach emptying, and stimulating insulin secretion from the pancreas.

The obesity treatment market is expected to reach a valuation of $100 billion by 2030, suggesting significant revenue and growth prospects for pharmaceutical companies like Novo Nordisk and Eli Lilly. Extending these treatments to younger populations could be especially profitable, as the long-term nature of these therapies means patients are likely to remain on them to maintain weight loss.

The study also noted that children who stopped taking Saxenda experienced a rebound in BMI, indicating the necessity of continued use for sustained results.