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Study of semaglutide treatment for adolescents with obesity caused by antipsychotic medications

Registered drug

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What is this trial about?

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

This study focuses on young people aged 12-18 who have developed obesity as a side effect of taking antipsychotic medications. The purpose is to examine how well a treatment using semaglutide (Wegovy) works alongside standard care for managing weight in these young patients. Semaglutide belongs to a group of medications called GLP-1 receptor agonists, which can help with weight management.

The medication used in this study is called Wegovy, which comes as a solution in a pre-filled injection pen. It is given as a subcutaneous injection, which means the medication is injected under the skin. The treatment starts with a lower dose and gradually increases over time, with different strength pens available (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg).

The treatment period lasts for 34 weeks, during which participants receive regular medical check-ups. During the study, various health measurements are taken, including body weight, body composition (the amount of fat and muscle in the body), and other health indicators. After the main treatment period ends, there is an additional 6-month follow-up period to monitor the participants' progress.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
Your treatment begins with Wegovy injections under the skin (subcutaneous)
The treatment starts with a low dose of 0.25 mg using a pre-filled injection pen
The medication will be given once per week
Step 2
Dose increase period
Your dose will gradually increase over several weeks
The dose progression will be: 0.5 mg, then 1.0 mg, then 1.7 mg, finally reaching 2.4 mg
Each dose will be given using specific pre-filled pens designed for that dose level
Step 3
Regular monitoring
Your weight, waist size, and hip measurements will be taken regularly
Blood pressure and heart rate checks will be performed
Blood samples will be collected to monitor your body's response to the treatment
Body composition will be measured using special scanning equipment
You will need to keep a diary recording your diet, exercise, and medications
Step 4
Treatment duration
The total treatment period will last 34 weeks
The main assessment of the treatment's effect will occur at week 32
You may continue your regular antipsychotic medication during the study, with dose adjustments if needed
Step 5
Follow-up period
After the main treatment period, there will be a 6-month follow-up period
During this time, your continued use of the medication will be assessed

Who can join the trial?

7 criteria

Age between 12 and 18 years old
Have a high body mass index (BMI) that is above the 90th percentile on Danish growth charts
Have a body fat percentage that is above the 95th percentile, as measured by a special device that analyzes body composition
Must be on stable antipsychotic medication for at least 4 weeks before joining the study (medication dose may be adjusted during the study if needed)
Must provide verbal agreement to participate in the study if under 15 years old, along with written permission from parent or legal guardian
Must provide both verbal and written consent if 15 years or older, along with parent/guardian consent
Female participants must agree to use birth control methods throughout the entire study period

Who cannot join the trial?

13 criteria

Age below 10 or above 17 years
Not being treated with antipsychotic medications (drugs used to manage mental health conditions)
Having a Body Mass Index (BMI) below the obesity threshold for age and sex
Known allergies to GLP-1 receptor agonists (the type of medication being studied)
Having type 1 or type 2 diabetes
Current or past history of pancreatitis (inflammation of the pancreas)
Severe kidney or liver problems
Currently participating in other clinical trials
Pregnancy or breastfeeding
Unable to understand or follow study instructions
History of severe eating disorders
Serious medical conditions that could interfere with the study
Not having parent or legal guardian consent

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Investigated drugs

GLP-1 receptor agonist (GLP-1 RA)
is a medication that helps control blood sugar levels and can assist with weight loss. It works by mimicking a natural hormone in the body that helps reduce appetite and food intake. In this trial, it is being studied as a potential treatment for young people who have gained weight while taking antipsychotic medications.
Antipsychotic medications
are used to treat various mental health conditions, but they can often cause weight gain as a side effect. These medications help manage mental health symptoms by affecting certain chemicals in the brain, but the weight gain they can cause is a significant concern for many patients, especially young people.

Semaglutide

What is already known about the treatment

GLP-1 receptor agonist - A class of injectable medications that mimics the natural hormone GLP-1 (glucagon-like peptide-1) to help regulate blood sugar and appetite control. This medication works by stimulating insulin production, slowing down digestion, and reducing hunger signals in the brain, making it effective for treating obesity, particularly in cases related to antipsychotic medication use. GLP-1 receptor agonists are administered via subcutaneous injection and represent a modern approach in obesity management, especially significant in pediatric and adolescent populations where treatment options are limited. The medication belongs to the incretin mimetic class of drugs and has shown promising results in clinical trials for weight management, while also helping to maintain blood sugar control.

Investigated diseases

Obesity - A chronic medical condition characterized by excessive accumulation of body fat that surpasses healthy levels. The condition develops when the body consistently takes in more calories than it uses, leading to increased fat storage. Body fat accumulates gradually over time, affecting various body systems and metabolic processes. Obesity can be influenced by genetic factors, lifestyle choices, and environmental conditions. The condition often develops alongside changes in body composition, including increased fat mass and alterations in fat distribution throughout the body.