Liraglutide lowered BMI in children ages 6 to 11 in SCALE Kids trial
A 56-week trial found liraglutide reduced BMI in children ages 6 to 11 with obesity, but no GLP-1 drug is FDA-approved for that age group.
Children aged 6 to under 12 with obesity who received once-daily liraglutide injections along with lifestyle interventions had a mean BMI change of −5.8 percent after 56 weeks, compared with +1.6 percent for children who received placebo plus lifestyle interventions [1][2]. That is an estimated difference of −7.4 percentage points (95% confidence interval, −11.6 to −3.2; P<0.001), according to the SCALE Kids results published in the New England Journal of Medicine issue dated February 6, 2025, after first appearing online on September 10, 2024 [1].
The trial randomly assigned 82 children in a 2:1 ratio: 56 to liraglutide and 26 to placebo [1][2]. It was a phase 3a study with a 56-week treatment period followed by a 26-week follow-up period [1][2]. Liraglutide, a GLP-1 receptor agonist, was given as a once-daily subcutaneous injection at 3.0 mg, or the highest dose each child could tolerate, and both groups also received lifestyle interventions [1][2]. The main measure was the percentage change in BMI, which is weight in kilograms divided by the square of height in meters [1][2]. Researchers also tracked the percentage change in body weight and how many children reduced BMI by at least 5 percent [1][2].
On body weight, the liraglutide group had a mean change of +1.6 percent versus +10.0 percent with placebo, a difference of −8.4 percentage points (95% CI, −13.4 to −3.3; P=0.001) [1][2]. A BMI reduction of at least 5 percent occurred in 46 percent of children taking liraglutide and 9 percent taking placebo (adjusted odds ratio, 6.3; 95% CI, 1.4 to 28.8; P=0.02) [1][2].
Side effects were common in both groups. Adverse events were reported in 89 percent of children taking liraglutide and 88 percent taking placebo, and serious adverse events in 12 percent and 8 percent, respectively [1][2]. Gastrointestinal adverse events, such as nausea and vomiting, were more frequent with liraglutide: 80 percent versus 54 percent [1][2].
The trial was funded by Novo Nordisk and registered as NCT04775082 [1][2]. Results from the 26-week follow-up period after treatment ended have not been reported in the published abstract, so it is not yet known from these results whether the BMI difference persisted once children stopped the drug [1][2].
Why it matters for patients
No medication is currently approved to treat nonmonogenic, nonsyndromic obesity in children younger than 12 in the United States [1][2]. That means families of younger children with obesity have had no FDA-approved drug option of this kind, and this trial is the first phase 3 randomized test of liraglutide in this age group reported in the New England Journal of Medicine [1][2].
The difference between groups was driven partly by weight gain in the placebo group, which rose 10.0 percent on average, while the liraglutide group was roughly flat at +1.6 percent [1][2]. The trial was small — 82 children total, 26 of them on placebo — so the estimates of benefit and risk carry wide statistical ranges, including the confidence interval for the 5 percent BMI reduction measure, which ran from 1.4 to 28.8 [1][2].
Gastrointestinal side effects were substantially more common with liraglutide, and about one in eight children on the drug had a serious adverse event, compared with about one in twelve on placebo [1][2]. The published results do not report effects on growth, puberty or other long-term outcomes in children this age, and the trial's design does not establish what happens after the drug is stopped [1][2].
What happens next
The trial included a 26-week follow-up period after the 56 weeks of treatment, but those results have not been reported [1][2]. Whether Novo Nordisk has filed or plans to file for FDA approval of liraglutide for obesity in children under 12 has not been disclosed [1][2]. Liraglutide is not among the semaglutide products (Ozempic, Wegovy, Rybelsus) or tirzepatide products (Mounjaro, Zepbound) that dominate current GLP-1 prescribing; it is a separate molecule [1][2].
Sources
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