Liraglutide Appears Safe and Effective for Weight Loss in Children

A widely prescribed medicine for type 2 diabetes and adult weight management appears to offer safe, effective short-term weight loss for children, according to newly reported findings.

Liraglutide, sold as Victoza and Saxenda, is in the same drug class as semaglutide, the active medicine behind Ozempic and Wegovy.

The subcutaneous injection gained US approval in 2010 as an add-on treatment for type 2 diabetes. It was subsequently approved, four years later, for weight management in adults classified as overweight or obese.

Liraglutide use in children

Although liraglutide and related medicines have become increasingly popular, their long-term effects are still under investigation, including in adults. Their use in children is particularly contentious.

Some researchers have cautioned that liraglutide could pose dangers or create unforeseen long-term effects in children. However, the US Food and Drug Administration authorised liraglutide in 2019 for patients aged 10 and above with type 2 diabetes.

No medicines have yet been approved to treat obesity in children under 12 years old.

A phase 3 clinical trial involving 82 participants has now produced early evidence that liraglutide, alongside other lifestyle measures, is safe and effective as a weight loss medicine for children as young as six.

Weight loss results and lifestyle support

Around one year after entering the Novo Nordisk-funded trial, children aged between 6 and 12 who received liraglutide had reduced their body mass index by 5.8 percent. Over the same timeframe, BMI increased by about 1.6 percent among those who received a placebo.

As children in this age group are still developing, some weight gain over a year would be anticipated in the absence of drug treatment.

Every child taking part received guidance from qualified healthcare professionals and was encouraged to follow a healthy diet and exercise for roughly an hour each day.

"In our study, diastolic blood pressure and… a measure of blood sugar control improved more in children receiving liraglutide than in those receiving the placebo," explains lead researcher and paediatrician Claudia Fox from the University of Minnesota Twin Cities. Fox has received grant and contact support from Novo Nordisk and another pharmaceutical company, Eli Lilly.

Negative side effects occurred at broadly similar rates in the two groups. Temporary gastrointestinal problems, including nausea and vomiting, were nearly 30 percent more frequent in the liraglutide group, however.

"To date, children have had virtually no options for treating obesity," argues Fox.

"They have been told to 'try harder' with diet and exercise. 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."

Concerns over BMI rebound and long-term effects

In an accompanying editorial, paediatricians Julian Hamilton-Shield and Timothy Barrett say Fox and her team have supplied "much-needed evidence" on liraglutide's effects in young children with obesity.

They also point out that the trial did not assess body composition, while BMI is an inadequate proxy for fat mass.

Once treatment ended, children assigned to liraglutide recorded rising BMI scores, "which is worrisome because it implies the ongoing need for pharmacotherapy to prevent BMI rebound," Hamilton-Shield and Barrett explain.

Similar issues affect adults who take these medicines. Research has shown that, after stopping the injections, the average patient generally regains roughly two-thirds of the weight they lost within a year.

Large weight changes during childhood may present a substantial risk to continuing development.

In commentary published last year, several scientists with no declared conflicts of interest warned that "little attention has been paid to the possible unintended consequences or adverse impact of these medications on children and adolescents during their critical period of growth and development."

As the long-term side effects of incretin mimetics are still becoming apparent in adults, there is ample reason for caution.

The study was published in the New England Journal of Medicine.