Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted globally.

The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 251 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: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation. BMI corresponding to equal to or above 30 kg/m\^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity). Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change). History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: pre-pubertal subjects (tanner stage 1) at screening v2; type 1 diabetes mellitus (t1dm); family or personal history of multiple endocrine neoplasia type 2 (men2).

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2016-09-29 with completion listed for 2019-02-14.

It ran at 33 sites in United States (13), Russia (8), Belgium (6), Sweden (4) and Mexico (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in BMI SDS (Week 0, Week 56) (time frame: Week 0, week 56).

It also tracked 60 secondary outcomes, for example Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)), Change in BMI, Change in Body Weight (kg), Change in Body Weight (%), Change in Body Weight (lb) and Change in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 251 people.

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

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