Liraglutide Appears Safe and Effective for Weight Loss in Children

Liraglutide, a widely used prescription medicine for treating type 2 diabetes and managing weight in adults, appears to be safe and effective for helping children lose weight - at least over the short term - according to newly reported findings.

Liraglutide, sold under the brand names Victoza and Saxenda, is in the same medication class as semaglutide, the active drug in Ozempic and Wegovy.

Liraglutide approvals and use in children

The injection, which is administered under the skin, received US approval in 2010 as an add-on treatment for type 2 diabetes. In 2014, it was also approved for weight management in adults considered overweight or obese.

Although these medicines have become increasingly popular, researchers are still examining the long-term effects of liraglutide and related drugs, including in adults. Their use in children is particularly disputed.

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

At present, no medicines are approved to treat obesity in children under 12.

Trial results for liraglutide weight loss

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

Around one year after the Novo Nordisk-funded trial began, participants aged 6 to 12 who received liraglutide had reduced their body mass index by 5.8 percent. Over the same timeframe, children receiving a placebo had BMI increases of roughly 1.6 percent.

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

Every child enrolled in the study received advice 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," 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. However, short-lived gastrointestinal problems, including nausea and vomiting, were almost 30 percent more frequent among children given liraglutide.

"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 long-term treatment

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

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

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

Adults using these medicines face similar concerns. Research has shown that after injections are discontinued, the average patient generally regains around two-thirds of the weight they lost within a year.

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

In commentary published last year, several scientists who declared no 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 adverse effects of incretin mimetics are still emerging among adults, there is ample reason for caution.

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