Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity

What Was Tested

This registered phase 4 trial tested Liraglutide.

Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone for 6 months.

It had two arms (groups): Liraglutide + Lifestyle Intervention (experimental) and Lifestyle Intervention Alone (no intervention).

The registry classes the interventions as drug.

More on the Plan

Conventional echocardiographic parameters may not detect early changes.

This is a prospective, randomized, controlled, open-label clinical trial including children aged 6-12 years with severe obesity (BMI Z-score ≥ +3).

Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone.

Participants are followed for 6 months with clinical, laboratory, imaging, and functional assessments.

Who Took Part

The registry lists 30 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: Children aged 6-12 years. BMI Z-score ≥ +3. Previous unsuccessful lifestyle intervention.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: severe chronic diseases; cardiac disease; dermatological contraindication.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2024-03-30 with completion listed for 2027-04.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Body Mass Index (BMI) (time frame: 6 months).

It also tracked 8 secondary outcomes, for example Change in left ventricular global longitudinal strain (LV-GLS) measured by two-dimensional speckle-tracking echocardiography, Change in left atrial reservoir strain (LASr) measured by two-dimensional speckle-tracking echocardiography, Change in fasting plasma glucose, Change in fasting insulin levels, Change in triglyceride levels and Change in total cholesterol levels.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 30 people.

Its size is small, so on its own it can only give an early look.

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.