A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in the United States of America.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 7 years up to 11 years.

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

Examples of who could join: Male or female subjects aged 7-11 years (both inclusive) at the time of signing informed consent. Tanner stage 1 (including subjects with premature adrenarche) at the time of signing informed consent.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: subjects with secondary causes of childhood obesity (i.e., hypothalamic, genetic or endocrine causes); subjects with confirmed bulimia nervosa disorder; history of pancreatitis (acute or chronic).

How the Study Was Run

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

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2016-03-14 with completion listed for 2017-04-13.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of treatment emergent adverse events.

It also tracked 1 secondary outcome, for example Area under the liraglutide concentration curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 24 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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