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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Bispebjerg Hospital	København S	Denmark

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	03.03.2025

Trial locations

Investigated Drugs:

Semaglutide

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.

Investigated Diseases:

Obesity

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.

Trial ID:

2024-517471-21-02

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?