Novo Nordisk said children between the ages of 6 and 12 saw a 7.4% reduction in BMI over about a year in a late-stage trial investigating its weight loss drug Saxenda in a pediatric population.
The data, which were shared Tuesday at the European Association for the Study of Diabetes’ annual meeting in Madrid, also showed that the children saw an improvement in blood pressure and blood sugar control.
The Phase 3 trial, dubbed SCALE Kids, is the first to investigate the GLP-1 in the pediatric population, according to the company. Saxenda, also known as liraglutide, has been approved for weight management in adults since 2014 and adolescents since 2020. It’s also Novo’s first GLP-1 on the market, preceding its megablockbuster Wegovy for weight loss.
The 52-week Phase 3 trial included 82 children, with 54.9% of them having one or more obesity-related complication, such as insulin resistance or early puberty.
Novo’s trial also assessed other data measurements like change in BMI. At the end of treatment, the mean reduction in BMI was 5.8% for the Saxenda group and 1.6% for placebo. A reduction in BMI of at least 5% was seen in 46.2% of children on Saxenda and 8.7% on placebo. BMI and body weight both increased after treatment ended.
Martin Holst Lange“Before doing studies in children, you want to be sure that you have established safety and efficacy in adults,” Martin Holst Lange, Novo’s executive VP and head of development, told Endpoints News. “We’ve done that.”
Lange added that the CDC estimates one in five children have obesity, which is a predictor for having obesity in adulthood.
“Therefore, having data and potential treatment options is relevant, both for regulators but also what we hear from the treating physician perspective,” Lange said.
Safety data showed that 89.3% of those taking Saxenda and 88.5% on placebo had side effects. The most common were gastrointestinal in nature, with a little over 80% of those on Saxenda experiencing issues like nausea and vomiting. In the Saxenda group, 12.5% had serious side effects. Four of the seven events were gastrointestinal, and 10.7% of those in the liraglutide group discontinued treatment due to side effects.