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

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

7 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Porto, Portugal
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Verified
Unidade Local De Saúde De Santa Maria, E.P.E.
Lisbon, Portugal

Trial locations

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Investigated drugs

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.

Liraglutide

What is already known about the treatment

Liraglutide – Liraglutide is administered as a subcutaneous injection, typically given once daily. It is currently being studied in clinical trials for its effectiveness and safety in managing weight in children with obesity. The main therapeutic indication for liraglutide is obesity management. At the molecular level, liraglutide works by mimicking a hormone called GLP-1, which helps regulate appetite and food intake. It is classified as a GLP-1 receptor agonist in pharmacology.

Investigated diseases

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.