Study on Semaglutide and Low Energy Diet for Obesity in Adolescents Aged 12-17

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What is this study about?

This clinical trial is focused on studying obesity in adolescents aged 12 to under 18 years. The treatment being tested is a medication called Semaglutide, which is given as a solution for injection. The study will compare the effects of Semaglutide with a placebo, both used alongside a program that combines face-to-face and electronic behavioral therapy. This program is designed to help participants manage their weight through lifestyle changes.

The purpose of the study is to determine if Semaglutide is more effective than a placebo in reducing body weight in adolescents with obesity. Participants will first undergo an 8-week program that includes a low-energy diet, followed by a 52-week treatment period where they will receive either Semaglutide or a placebo once a week. The study will monitor changes in body weight, as well as other health factors such as physical activity, sleep, and quality of life.

Throughout the study, researchers will also observe any side effects and changes in health markers like blood sugar and blood pressure. The goal is to understand how Semaglutide can help adolescents with obesity achieve better health outcomes. The study is expected to continue until 2027.

1 initial phase

The trial begins with an 8-week program combining face-to-face and electronic low energy diet (eLED) sessions. This phase is designed to prepare participants for the main treatment phase.

2 main treatment phase

Participants will receive either semaglutide or a placebo. The medication is administered as a solution for injection.

The dosage for semaglutide is 2.4 mg, given once a week.

This phase lasts for 52 weeks and includes a combination of face-to-face and electronic behavioral therapy (eBT).

3 monitoring and assessment

Throughout the trial, participants’ body weight and body mass index (BMI) will be monitored to assess changes.

Additional assessments will include physical activity, sleep patterns, psychiatric symptoms, eating disorder symptoms, and overall health-related quality of life.

Changes in fat mass, fat-free mass, blood glucose, blood lipids, and blood pressure will also be evaluated.

4 completion and follow-up

The trial is expected to conclude by March 2027.

Upon completion, participants will undergo final assessments to evaluate the overall effectiveness of the treatment.

Who Can Join the Study?

The participant’s parent(s) or legally authorized representative must give their permission, and the adolescent must agree to participate before any trial activities begin. Trial activities include any procedures done as part of the study.
The participant must be between 12 and 18 years old at the time of giving consent.
The participant must be an adolescent seeking treatment for obesity. This means having a Body Mass Index (BMI) of 35 or higher, or a BMI of 30 or higher with at least one other health issue related to weight, as determined by a doctor. BMI is a measure that uses height and weight to estimate body fat.
The participant must have tried at least once to lose weight through diet but was not successful.
The participant must be able to sign a consent form, which means they understand and agree to follow the rules and requirements of the study.

Who Cannot Join the Study?

Patients who are not between the ages of 12 and 18 years old.
Patients who do not have obesity.
Patients who are not willing to participate in a 52-week program that includes both face-to-face and electronic behavioral therapy.
Patients who cannot complete an initial 8-week program that includes both face-to-face and electronic low-energy diet sessions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Vestfold Hospital Trust	Tonsberg	Norway
St. Olavs Hospital HF	Trondheim	Norway
Nordlandssykehuset HF	Bodo	Norway
Finnmarkssykehuset HF	Hammerfest	Norway
Hrems Bvlssw Hm	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.01.2024

Trial locations

Investigated drugs:

Semaglutide

Semaglutide: This medication is used in the trial to help reduce body weight in adolescents with obesity. It is administered once a week through an injection under the skin. The trial aims to see if semaglutide is more effective than not using it, in combination with a special diet and behavioral therapy, in helping adolescents lose weight.

Low Energy Diet (LED): This is a diet plan that provides fewer calories than usual to help with weight loss. In the trial, participants follow this diet for an initial period to kickstart weight loss. The diet is part of a comprehensive program that includes both face-to-face and electronic support to help adolescents manage their weight.

Behavioral Therapy: This therapy is a combination of face-to-face and electronic sessions designed to support adolescents in changing their eating and activity habits. The goal is to help them achieve and maintain a healthier weight. The therapy is an important part of the trial, working alongside the medication and diet to support weight loss.

Investigated diseases:

Obesity

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. Obesity develops when calorie intake consistently exceeds calorie expenditure, leading to energy imbalance. Over time, this can result in increased fat storage in the body. The condition can progress to cause various health issues, including joint problems, sleep disturbances, and metabolic disorders. Lifestyle factors, genetics, and certain medical conditions can contribute to the development and progression of obesity.

Trial ID:

2023-506289-29-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Semaglutide and Low Energy Diet for Obesity in Adolescents Aged 12-17

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?