Study on Liraglutide for Weight Management in Children Aged 6 to 12 with Obesity

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What is this study about?

This clinical trial is focused on studying obesity in children aged 6 to under 12 years. The treatment being tested is a medication called liraglutide, which is administered as a solution for injection. The study will compare the effects of liraglutide with a placebo to see how well it helps with weight management in children with obesity.

The purpose of the study is to evaluate the effectiveness and safety of liraglutide in managing weight. Participants will receive either liraglutide or a placebo once daily for a period of 56 weeks. Throughout the study, various health measurements will be taken to monitor changes in body weight, body mass index (BMI), and other health indicators.

This research aims to provide valuable insights into how liraglutide can be used to support weight management in children with obesity. The study is designed to ensure the safety and well-being of all participants while gathering important data on the potential benefits of the treatment.

1 joining the study

Upon joining the study, the child must have informed consent from their parent or legal representative, and the child’s assent if age-appropriate. This is required before any trial-related activities begin.

2 initial assessment

The child will undergo an initial assessment to confirm eligibility. This includes checking age, pubertal development stage, and body mass index (BMI) to ensure it is at or above the 95th percentile for their age and gender.

3 treatment phase

The child will receive either liraglutide 3.0 mg or a placebo. The medication is administered as a subcutaneous injection once daily. This phase lasts for 56 weeks.

The primary goal is to observe changes in BMI from the start of the trial to week 56.

4 monitoring and assessments

Throughout the 56-week period, the child’s weight, BMI, waist circumference, and blood pressure will be regularly monitored.

Blood tests will be conducted to measure changes in HbA1c, which is a marker of blood sugar levels.

5 safety evaluation

The study will track any adverse events or serious adverse events from the start of the trial to week 82 to ensure the safety of the treatment.

6 completion of the trial

At the end of the 56-week treatment phase, the child’s progress will be evaluated based on the changes in BMI and other health markers.

The trial is expected to conclude by January 15, 2027.

Who Can Join the Study?

The parent(s) or legal representative of the child must give their permission for the child to join the study. The child must also agree to participate, if they are old enough to understand.
The child must be a boy or girl aged between 6 and less than 12 years old at the time of giving permission to join the study.
The child must be at a certain stage of development, known as Tanner stage 1-5, which describes physical growth during puberty.
The child must have a Body Mass Index (BMI) at or above the 95th percentile for their age and gender. This means their weight is higher than 95% of children of the same age and gender.
The child must have tried to lose weight through lifestyle changes, like diet and exercise, but was not able to lose enough weight, as determined by the study doctor.
If the child has Type 2 Diabetes (T2D), their blood sugar level, measured by a test called Haemoglobin A1c (HbA1c), must be 10.0% or lower at the start of the study.

Who Cannot Join the Study?

Children who are not between the ages of 6 and less than 12 years old.
Children who do not have obesity. Obesity means having too much body fat, which can affect health.
Children who have any medical condition that the study doctors think might make it unsafe for them to participate.
Children who are taking medications that could interfere with the study treatment.
Children who have participated in another clinical trial recently.
Children who have a history of certain medical conditions that the study doctors think might affect the study results.
Children who are unable to follow the study procedures as required.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Hospital Da Luz S.A.	Lisbon	Portugal
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Vrije Universiteit Brussel	Jette	Belgium
Hospital CUF Porto S.A.	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	04.03.2021
Portugal	Not recruiting	04.03.2021

Trial locations

Investigated drugs:

Liraglutide

Liraglutide is a medication used in this trial to help manage weight in children with obesity. It is given as an injection under the skin once a day. The goal of using liraglutide in this study is to see how well it helps children lose weight and to check its safety for this age group.

Investigated diseases:

Obesity

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It is typically measured using the Body Mass Index (BMI), which is a ratio of weight to height. As obesity progresses, individuals may experience increased body weight and changes in body composition. This condition can lead to various health issues, including increased blood pressure and altered blood sugar levels. Obesity often results from a combination of genetic, environmental, and lifestyle factors. It can affect individuals of all ages, including children, and may require long-term management strategies.

Trial ID:

2023-508504-38-00

Protocol code:

NN8022-4392

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Liraglutide for Weight Management in Children Aged 6 to 12 with Obesity

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?