Novo Nordisk's GLP-1 cuts children's BMI by 7% in Phase 3 trial

Novo Nordisk recently revealed promising data from a late-stage clinical trial investigating its weight loss drug Saxenda in children aged 6 to 12. The Phase 3 trial, named SCALE Kids, demonstrated a significant reduction in Body Mass Index (BMI) and improvements in blood pressure and blood sugar control among participants.

The findings were presented at the European Association for the Study of Diabetes’ annual meeting in Madrid. Over the course of about a year, children taking Saxenda experienced an average BMI reduction of 7.4%. This trial marks the first time Saxenda, also known as liraglutide, has been tested in a pediatric population. Saxenda has been approved for weight management in adults since 2014 and for adolescents since 2020, making it Novo Nordisk’s initial GLP-1 offering prior to their blockbuster weight loss drug, Wegovy.

The 52-week trial involved 82 children, with over half of them presenting one or more obesity-related complications such as insulin resistance or early puberty. In terms of BMI reduction, children in the Saxenda group saw an average decrease of 5.8%, compared to a 1.6% reduction in the placebo group. Additionally, 46.2% of children on Saxenda achieved a BMI reduction of at least 5%, compared to just 8.7% of those on placebo. However, both BMI and body weight increased after the treatment period ended.

Martin Holst Lange, Novo Nordisk’s executive VP and head of development, emphasized the importance of first establishing safety and efficacy in adults before extending studies to children. Lange noted that the Centers for Disease Control and Prevention (CDC) estimates that one in five children have obesity, a condition that often continues into adulthood. He stressed the relevance of having data and potential treatment options for regulators and healthcare providers.

Regarding safety, 89.3% of children taking Saxenda experienced side effects, compared to 88.5% in the placebo group. The most common side effects were gastrointestinal, with over 80% of the Saxenda group reporting issues such as nausea and vomiting. Serious side effects were noted in 12.5% of the Saxenda group, with four out of seven serious events being gastrointestinal in nature. Additionally, 10.7% of participants in the Saxenda group discontinued treatment due to side effects.

The data from this trial suggest that Saxenda could be a viable option for managing obesity in children, potentially providing a new tool for healthcare providers to combat the rising trend of childhood obesity.

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