Study backs role of Novo Nordisk obesity drug in children

A clinical trial has backed the safety and efficacy of one of Novo Nordisk's weight-loss medicines in children as young as six, showing a significant drop in body mass index (BMI).

The study used the company's older GLP-1 agonist therapy Saxenda (liraglutide), which requires a daily injection, rather than its top-selling once-weekly obesity drug Wegovy (semaglutide), and focused on children aged six to 11 with an average BMI of 31, putting them in the obesity category.

There are no FDA-approved therapies for this age group, although, Wegovy has been cleared since 2022 for use in children and adolescents aged 12 and over, and Saxenda for the same age range since 2020. Novo Nordisk has filed for approval to extend the labelling for Saxenda to include children aged six to 11.

There are concerns about the use of pharmacological interventions like Saxenda to treat obesity in children, particularly as BMI rose after the drug was discontinued in the trial, suggesting that they may have to stay on treatment long-term and the long-term effectiveness and safety of the drug in children remains unknown.

On the other hand, obesity among children is a rising problem in the US, affecting one in five kids in the six to 11 bracket, according to the Centers for Disease Control and Prevention (CDC), and there are of course well-established health problems associated with being overweight from such a young age.

Last year, the American Academy of Paediatrics included drugs as an option for children with obesity in its treatment guidelines for the first time, albeit only in the over-12s given the lack of treatment options for younger children.

In the new SCALE Kids study, which has been published in the New England Journal of Medicine, a daily 3mg dose of Saxenda reduced the body mass index (BMI) of the children by an average of 5.8% over 56 weeks of follow-up, compared to a 1.6% increase for those on placebo.

The proportion of children reaching a 5% improvement in BMI was 46% with Saxenda and 9% with placebo. Average body weight fell by 1.6% with the drug, but rose 10% in the control group, although, the researchers focused on BMI, rather than weight, as children of those ages can be markedly different in size and grow at different rates.

Lead author Professor Claudia Fox, a childhood obesity specialist at the University of Minnesota Medical School in Minneapolis, pointed out that, left untreated, childhood obesity "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 critical, but changes in diet and physical activity bring modest benefits and treatment options are limited, according to Fox.

"Although there is no consensus on the definition of a clinically meaningful BMI reduction in children, a 5% reduction has previously been shown to be associated with improvement in some obesity-related health conditions," Prof Fox said.

There were accompanying benefits with Saxenda in reduced blood pressure and blood glucose, and side effects – mainly gastrointestinal reactions like nausea, vomiting, and diarrhoea – were in line with other studies of GLP-1 agonists for weight loss.

"To date, children have had virtually no options for treating obesity. They have been told to 'try harder' with diet and exercise," said Fox. "Now, with the possibility of a medication that addresses the underlying physiology of obesity, there is hope that children living with obesity can live healthier, more productive lives."