A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

This study will look at the change in teenagers' body weight from the start to the end of the study.

This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine.

The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight.

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

Placebo injected s.c. once weekly .

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 201 actual participants took part.

It was open to people of any sex aged from 12 years up to 17 years.

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

Examples of who could join: Male or female, ages 12 to below 18 years at the time of signing informed consent. History of at least one self-reported unsuccessful dietary effort to lose weight.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: prepubertal subjects (tanner stage 1); history of type 1 diabetes; subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes).

How the Study Was Run

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

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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2019-10-07 with completion listed for 2022-03-25.

It ran at 51 sites in United States (23), Russia (7), United Kingdom (6), Belgium (4), Ireland (4) and Austria (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Body Mass Index (BMI) (Percentage [%]) (time frame: Baseline (week 0), week 68).

It also tracked 37 secondary outcomes, for example Change in Body Weight (Kilograms [kg]), Change in Body Weight (%), Change in BMI (Standard Deviation Score [SDS]), Change in BMI (Kilograms Per Meter Square [kg/m^2]), Change in Waist Circumference and Change in Systolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 201 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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