Trial Finds Liraglutide Safe and Effective for Weight Loss in Children

A widely prescribed medicine for type 2 diabetes and adult weight management appears to be safe and effective for helping children lose weight, at least over the short term, according to newly released findings.

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

The injectable treatment, administered beneath the skin, received US approval in 2010 as an additional treatment for type 2 diabetes. Four years afterwards, it was also authorised for weight management in adults considered overweight or obese.

Liraglutide use and approval for 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 contested.

Some researchers have cautioned that liraglutide could be harmful or cause unforeseen long-term effects in children. Nevertheless, in 2019 the US Food and Drug Administration approved liraglutide for patients aged 10 and above with type 2 diabetes.

At present, no medicines have been approved to treat obesity in children under 12 years old.

Trial results for liraglutide and weight loss

Initial findings from a phase 3 clinical trial involving 82 participants now suggest that liraglutide, when used alongside lifestyle measures, is both safe and effective as a weight-loss medicine for children as young as six.

Around one year after entering the trial, which was funded by Novo Nordisk, the manufacturer of liraglutide, participants aged from 6 to 12 who received liraglutide had lowered their body mass index by 5.8 percent. Over the same period, BMI rose by roughly 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 expected without drug treatment.

Every child taking part received guidance from qualified healthcare professionals and was encouraged to follow a healthy diet and undertake around an hour of exercise 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," says lead researcher and paediatrician Claudia Fox of the University of Minnesota Twin Cities. Fox has received grant and contact support from Novo Nordisk and another pharmaceutical company, Eli Lilly.

The rate of adverse effects was broadly similar in the two groups. However, temporary gastrointestinal problems, including nausea and vomiting, were nearly 30 percent more frequent in the liraglutide group.

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

"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 about BMI rebound and long-term effects

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

They point out, however, that the trial did not assess body composition and that BMI is a weak proxy for fat mass.

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

These concerns extend to adults using these medicines as well. Research has shown that, after stopping the injections, the average patient commonly regains around two-thirds of the weight they lost within a year.

Large changes in weight during childhood may pose a serious risk to continued development.

In a commentary published last year, several scientists, who declared no conflicts of interest, cautioned 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 adverse effects of incretin mimetics are still emerging in adults, there is every reason to proceed carefully.

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