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Study of Tirzepatide for Reducing Obesity and Related Health Issues in Adolescents

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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 the effects of a medication called Tirzepatide on adolescents who have obesity and related health issues. Tirzepatide is a solution for injection that is being tested to see if it can help reduce body mass index (BMI) and improve conditions related to excess weight. The study will compare the effects of Tirzepatide to a placebo, which is a substance with no active medication, to determine its effectiveness.

The purpose of the study is to find out if Tirzepatide can help adolescents achieve a healthier weight and improve their overall health. Participants in the study will receive injections of either Tirzepatide or a placebo once a week. The study will last for a period of up to 18 months, during which time the health and weight of the participants will be closely monitored.

Throughout the study, researchers will look at changes in BMI and any improvements in weight-related health issues. The goal is to see if Tirzepatide can provide significant benefits compared to the placebo. This research is important for understanding how to better manage obesity and its related health problems in young people.

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
Joining the study
Upon joining the study, eligibility is confirmed based on age (12 to 17 years) and a body mass index (BMI) equal to or above the 95th percentile for age and sex.
Step 2
Randomization
Participants are randomly assigned to receive either tirzepatide or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.
Step 3
Medication administration
Tirzepatide is administered as a solution for injection under the skin (subcutaneous) once a week. The exact dosage is determined by the study protocol.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess changes in BMI and any improvements in weight-related health issues. This includes tracking any new or worsening health conditions related to weight.
Step 5
Completion of the study
The study is estimated to conclude by April 2, 2027. At the end of the study, final assessments are conducted to evaluate the effectiveness of tirzepatide compared to the placebo.

Who can join the trial?

2 criteria

Be between 12 to 17 years old.
Have a BMI (Body Mass Index) that is equal to or above the 95th percentile for your age and sex. This means your BMI is higher than 95% of people your age and sex, according to the CDC-NCHS 2022 guidelines.

Who cannot join the trial?

10 criteria

Individuals who are not within the specified age range for the study.
Individuals who have medical conditions that could interfere with the study or make participation unsafe.
Individuals who are currently participating in another clinical trial.
Individuals who have had recent surgery or are planning to have surgery during the study period.
Individuals who are pregnant or breastfeeding.
Individuals who have a history of certain medical conditions, such as heart disease or uncontrolled diabetes.
Individuals who are unable to comply with the study procedures or follow-up visits.
Individuals who have allergies or reactions to the study medication or similar drugs.
Individuals who have a history of substance abuse or alcohol dependency.
Individuals who are taking medications that could interfere with the study results.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
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Marseille, France
Assistance Publique Hopitaux De Paris
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Paris, France
Centre Hospitalier Regional D'Angers
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Angers, France

Trial locations

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Investigated drugs

Tirzepatide is a medication being studied for its ability to help reduce body mass index (BMI) and improve weight-related health issues in adolescents. It is given once a week and is being compared to a placebo to see how effective it is in treating obesity and related health problems.

Tirzepatide

What is already known about the treatment

Tirzepatide – This medication is administered as an injection under the skin, typically once a week. It is currently being studied in clinical trials for its effectiveness and safety in treating obesity and related health issues in adolescents. Tirzepatide works by mimicking hormones that regulate blood sugar and appetite, helping to reduce body weight. It belongs to a class of drugs known as GLP-1 receptor agonists, which are used to manage weight and blood sugar levels.

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), where a BMI of 30 or higher is considered obese. The condition develops gradually over time, often due to a combination of genetic, behavioral, and environmental factors. Obesity can lead to various health issues, including heart disease, diabetes, and joint problems. It is often associated with an imbalance between calorie intake and energy expenditure. Managing obesity involves lifestyle changes, including diet and physical activity, to reduce body weight and improve overall health.