SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

What Was Tested

This registered phase 3 trial tested Liraglutide.

The study looks at how liraglutide works on participant's body weight.

Researchers will look at how liraglutide can help children with obesity to lose weight.

They will look at how much weight the children will lose, and if there are any side effects.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 78 planned participants were the target.

It was open to people of any sex aged from 6 years up to 12 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, aged 6 to below 12 years at the time of signing informed consent. Tanner stage 1-5 pubertal development at the time of signing informed consent. BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov). History of failing to lose sufficient weight with lifestyle modification as judged by the investigator.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: treatment with any medication for the indication of obesity within the past 90 days before screening; type 1 diabetes; subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-03-04 with completion listed for 2023-08-01.

It ran at 32 sites in United States (9), Portugal (8), Russia (4), Belgium (2), India (2) and Israel (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative change in BMI (Body mass index) (time frame: From baseline (week 0) to week 56).

It also tracked 11 secondary outcomes, for example Relative change in body weight, Change in BMI standard deviation score (WHO.int), BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov), Change in waist circumference, Change in systolic blood pressure and Change in diastolic blood pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 78 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.