A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

What Was Tested

The trial (phase 3) is built around Semaglutide.

This study will look at how well semaglutide helps children and teenagers losing weight.

This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine.

In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight.

It had two arms (groups): Group Kids (experimental) and Group Teens (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 212 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months. Body weight of greater than 45 kilogram (kg) at screening and randomisation.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening; type 1 diabetes mellitus or monogenic diabetes; participants with endocrine, hypothalamic, or syndromic obesity.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

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

It started in 2023-07-07 with completion listed for 2025-10-15.

It ran at 56 sites in United States (24), Germany (7), United Kingdom (5), Belgium (4), Sweden (4) and Denmark (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Group Kids: Change in body mass index (BMI) (time frame: From baseline (week 0) to week 68).

It also tracked 69 secondary outcomes, for example Group Teens: Change in BMI, Group Kids and Group Teens: Change in BMI, Group Kids and Group Teens: Change in body weight, Group Kids and Group Teens: Change in body weight, Group Kids and Group Teens: Change in body weight and Group Kids and Group Teens: Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 212 people.

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

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