Study on the Effects of Semaglutide for Weight Management in Children and Adolescents with Obesity or Overweight

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What is this study about?

This clinical trial is focused on studying the effects of a medication called semaglutide on managing weight in children and teenagers who are dealing with obesity or are overweight. The medication, known by the brand name Wegovy, is administered as a solution for injection using a pre-filled pen. The study aims to determine how well semaglutide, when used alongside a reduced-calorie diet and increased physical activity, can help manage weight in young individuals aged 6 to under 18 years.

Participants in the study will receive semaglutide injections once a week. The study will compare the effects of semaglutide with a placebo, which is a substance with no active medication, to see if semaglutide is more effective in helping children and teenagers lose weight. The study will last for a period of up to 104 weeks, during which participants will be monitored for changes in their body mass index (BMI), weight, and other health indicators.

The goal of the study is to confirm whether semaglutide is superior to a placebo in aiding weight management in children with obesity. The study will also look at improvements in weight categories based on growth charts specific to age and sex, as well as changes in other health markers such as blood pressure and cholesterol levels. This research is important for understanding how semaglutide can be used as a treatment option for young people struggling with obesity and overweight issues.

1 beginning of the trial

Upon joining the study, the participant will start with a baseline assessment. This includes measuring the body mass index (BMI) and other health indicators. This step is crucial to establish the starting point for the trial.

2 medication administration

The participant will receive a medication called semaglutide, which is administered as a subcutaneous injection (an injection under the skin).

The dosage will start at 0.25 mg once a week and will gradually increase over time. The participant will eventually receive a dose of 2.4 mg once a week.

The medication is provided in a pre-filled pen called Wegovy.

3 diet and physical activity

Participants are encouraged to follow a reduced-calorie diet and increase their physical activity as part of the trial. This is to support weight management efforts alongside the medication.

4 regular check-ups

Throughout the trial, participants will have regular check-ups to monitor their progress. These check-ups will include measuring changes in BMI and other health indicators.

The primary goal is to observe changes from the baseline to week 68 and further to week 104.

5 end of the trial

The trial is expected to conclude by January 15, 2027. At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on weight management.

Who Can Join the Study?

The parent(s) or legally acceptable representative (LAR) of the child must give their informed consent before any study-related activities begin. This means they agree to let their child participate in the study. The child must also agree to participate, either by signing a form or giving oral consent.
The child must be between the ages of 6 and less than 12 years old for Group Kids, or between 12 and less than 18 years old for Group Teens. For Group Teens, the child must also be at Tanner stage greater than 1, which is a measure of physical development.
The child’s Body Mass Index (BMI) must be at or above the 95th percentile for their age and gender. For Group Teens, if the BMI is between the 85th and 95th percentile, the child must have at least one weight-related health issue, such as high blood pressure, abnormal cholesterol levels, sleep apnea, or type 2 diabetes (T2D).
The child must have a history of at least one unsuccessful attempt to lose weight through a structured program that includes diet and exercise counseling for at least 3 months.
The child must weigh more than 45 kg (about 99 pounds) at the time of screening and randomization.
If the child has type 2 diabetes, they must be treated with lifestyle changes or metformin, a medication for diabetes, and this treatment must be stable for at least 90 days before screening.
If the child has type 2 diabetes, their HbA1c level, which is a measure of blood sugar control, must be 10.0% or lower at screening.
If the child is assessed by a DXA scan, which is a type of imaging test to measure body composition, the scan must be evaluated and found acceptable by the imaging laboratory before randomization.
If the child is assessed by a DXA scan, their BMI must be 40.0 kg/m² or lower at screening.

Who Cannot Join the Study?

Children who are not between the ages of 6 and 12 years old cannot participate.
Children who do not have obesity or are not overweight cannot participate.
Children who cannot follow a reduced-calorie diet or increase physical activity cannot participate.
Children who have any medical condition that the study doctors think might make it unsafe for them to participate cannot join the study.
Children who are taking medications that might interfere with the study cannot participate.
Children who have participated in another clinical trial recently may not be eligible.
Children who are pregnant or breastfeeding cannot participate.
Children who have a history of certain medical conditions, such as severe heart disease or uncontrolled diabetes, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaet Leipzig	Leipzig	Germany
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hospital Da Luz S.A.	Lisbon	Portugal
Universitaetsklinikum Ulm AöR	Ulm	Germany
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Vrije Universiteit Brussel	Jette	Belgium
Hannoversche Kinderheilanstalt	Hanover	Germany
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Region Halland	Varberg	Sweden
Region Sjaelland	Holbæk	Denmark
Hospital CUF Porto S.A.	Porto	Portugal
Uniklinikum Salzburg	Salzburg	Austria
Cfwdno Hcptvlwglu Ungdzqcjrfbtk Da Pzinr Ebqecj	Porto	Portugal
Upxuczv Ujxxzimdma Hhsdlqts	Uppsala	Sweden
Uvnmbjowao Oz Aejhivf	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	07.07.2023
Belgium	Not recruiting	07.07.2023
Denmark	Not recruiting	07.07.2023
Germany	Not recruiting	07.07.2023
Portugal	Not recruiting	07.07.2023
Sweden	Not recruiting	07.07.2023

Trial locations

Investigated drugs:

Semaglutide

Semaglutide is a medication used in this clinical trial to help manage weight in children and adolescents who are overweight or have obesity. It is given as an injection under the skin once a week. The goal of using semaglutide in this study is to see if it can help reduce weight when combined with a diet that has fewer calories and increased physical activity. The trial aims to confirm that semaglutide is more effective than not using any active medication (placebo) in helping children manage their weight.

Investigated diseases:

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this excess energy is stored as fat, resulting in increased body weight and body mass index (BMI). As obesity progresses, it can lead to changes in body composition, including increased fat mass and altered distribution of fat. This condition can also affect metabolic processes, potentially leading to changes in blood pressure, cholesterol levels, and insulin sensitivity. Obesity can further influence physical activity levels and overall quality of life.

Trial ID:

2022-502922-41-00

Protocol code:

NN9536-4512

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Semaglutide for Weight Management in Children and Adolescents with Obesity or Overweight

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