SCALE Kids reports liraglutide results in children aged 6 to under 12

A phase 3a trial called SCALE Kids tested daily liraglutide injections in 82 children ages 6 to under 12 who had obesity, comparing the drug plus lifestyle changes against placebo plus lifestyle changes over 56 weeks ^[1]. The results, published in a peer-reviewed report, showed a meaningful difference in body-mass index between the two groups, along with more gastrointestinal side effects in children who took the drug ^[1].

Children were randomly assigned in a 2-to-1 ratio, with 56 getting liraglutide at up to 3.0 mg once daily and 26 getting placebo ^[1]. At week 56, average BMI fell 5.8% in the liraglutide group, while it rose 1.6% in the placebo group, an estimated difference of 7.4 percentage points ^[1]. Body weight itself still rose in both groups, since children are growing, but it rose less with liraglutide: up 1.6% versus up 10.0% with placebo, a difference of 8.4 percentage points ^[1]. Nearly half of children on liraglutide, 46%, saw their BMI drop by at least 5%, compared with 9% on placebo ^[1].

Side effects were common in both groups. Overall adverse events occurred in 89% of children on liraglutide and 88% on placebo, so the two groups were similar on that broad measure ^[1]. But gastrointestinal problems, things like nausea or stomach upset, were more frequent with liraglutide: 80% of children on the drug had them versus 54% on placebo ^[1]. Serious adverse events were reported in 12% of the liraglutide group and 8% of the placebo group ^[1]. The trial was funded by Novo Nordisk, the maker of liraglutide, and registered as NCT04775082 ^[1].

Why it matters for patients

This trial is significant because no medication is currently approved in the United States for treating common, non-syndromic obesity in children younger than 12 ^[1]. Families of younger children with obesity have had few drug options, since existing GLP-1 medicines for weight management are approved starting at older ages. These results show liraglutide reduced BMI more than lifestyle changes alone did in this younger age group, at least over the 56-week study period ^[1].

At the same time, the higher rate of gastrointestinal side effects in the liraglutide group is a real trade-off that families and doctors would need to weigh if the drug were ever approved for this age range. The study also does not tell readers what happens after children stop the medication, since it included a 26-week follow-up period after treatment ended, but the sources provided here do not detail those follow-up results ^[1].

It is also not yet known, based on the sources reviewed, whether the FDA has acted on this trial data or whether liraglutide's approved age range in the United States has changed since this study was published. Readers should not assume the drug is currently approved for children under 12 based on this trial alone.

What happens next

The published report drew several published comments and replies in a major medical journal, indicating ongoing discussion among researchers about the findings ^[1]. Beyond that exchange, the sources here do not specify any additional regulatory filings, decisions, or timelines tied to this age group.