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Study on Semaglutide for Young Adults with Early-Onset Obesity Resistant to Lifestyle Changes

Verified siteRegistered drugNo placebo

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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 obesity in young adults who developed the condition during childhood. The study will use a treatment called semaglutide, which is a medication that helps regulate appetite and blood sugar levels. Semaglutide is administered through a subcutaneous injection, which means it is injected under the skin. In this study, semaglutide will be given at a dose of 2.4 mg over a period of 68 weeks.

The purpose of the study is to explore how effective semaglutide is in treating young adults with early-onset obesity, especially those who have not had success with lifestyle changes alone. Participants will be divided into groups based on their previous response to lifestyle interventions. Some participants will receive semaglutide, while others will receive a placebo. The study aims to understand the differences between those who respond well to lifestyle changes and those who do not.

Throughout the study, researchers will monitor changes in body weight and body composition, which refers to the proportion of fat and non-fat mass in the body. They will also track how many participants achieve significant weight loss, defined as losing at least 5%, 10%, 15%, or 20% of their body weight. The study is expected to provide valuable insights into the treatment of obesity in young adults and help identify the underlying mechanisms that make some individuals more resistant to lifestyle changes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Participants are divided into groups based on their response to previous lifestyle interventions. Group A includes those with a body mass index (BMI) of 30 or higher who did not respond to previous interventions. Group B includes those with a BMI of 30 or higher who had insufficient weight loss from previous interventions.
Step 2
Treatment phase
Participants receive the medication semaglutide through a subcutaneous injection, which means it is injected under the skin.
The dosage is 2.4 mg and is administered once a week for a duration of 68 weeks.
Step 3
Monitoring and follow-up
Throughout the study, regular follow-up visits are scheduled to monitor progress. These visits include assessments of weight, body composition, and overall health.
Participants are observed for any changes in body weight and composition, with specific attention to reductions of at least 5%, 10%, 15%, and 20%.
Step 4
Final assessment
At the end of the 68-week period, a final assessment is conducted to evaluate the overall effectiveness of the treatment.
The primary focus is on the change in BMI from the beginning to the end of the study, comparing the effects of semaglutide to a placebo.

Who can join the trial?

6 criteria

Age between 18 and 28 years old.
The time from the first treatment with the TCOC protocol to joining the study must be within 15 years.
Group A: Body Mass Index (BMI) of 30 or higher. These are people who did not respond to the TCOC protocol, meaning their BMI did not decrease significantly (less than 0.1 BMI SDS) over more than one year and they still have obesity (BMI of 30 or higher).
Group B: BMI of 30 or higher. These are people who had some response to the TCOC protocol, with a BMI decrease of more than 0.25 BMI SDS over more than one year, but they still have obesity (BMI of 30 or higher).
Group C: Only for initial examination. BMI less than 30. These are people who responded very well to the TCOC protocol, with a BMI decrease of more than 0.5 BMI SDS over more than one year and no longer have obesity (BMI less than 30).
Group D: Only for initial examination. Young adults who participated in The Holbaek Study and had normal weight development during childhood.

Who cannot join the trial?

5 criteria

Patients who are not young adults with childhood-onset obesity.
Patients who have not been resistant to structured lifestyle intervention.
Patients who have not responded with insufficient weight loss to the structured lifestyle intervention and do not remain obese.
Patients who are not willing to be treated with the medication semaglutide 2.4mg for 68 weeks.
Patients who are part of a vulnerable population.

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Verified sites

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Kobenhavns Universitet
Verified
Copenhagen, Denmark

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Investigated drugs

Semaglutide is a medication used in this clinical trial to help young adults who have had obesity since childhood. It is designed for those who have not been able to lose enough weight through lifestyle changes alone. Semaglutide works by mimicking a hormone in the body that helps control appetite, making you feel fuller and less hungry. This can help with weight loss when combined with a healthy diet and exercise. The trial aims to see how effective semaglutide is in helping these individuals lose weight over a period of time.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is administered as an injection under the skin, typically once a week. It is currently being studied for its effectiveness in treating obesity, particularly in young adults who have not had success with lifestyle changes alone. The main use of semaglutide is to help with weight loss in individuals with obesity. It works by mimicking a hormone in the body that helps regulate appetite, making you feel fuller and less hungry. Semaglutide belongs to a class of medications known as GLP-1 receptor agonists, which are used to manage blood sugar levels and support weight loss.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when there is an imbalance between calories consumed and calories expended, leading to an energy surplus stored as fat. Over time, this excess fat can accumulate in various parts of the body, particularly around the abdomen, hips, and thighs. The progression of obesity can lead to increased body mass index (BMI), which is a measure of body fat based on height and weight. As obesity progresses, it can affect the body's metabolism and increase the risk of developing other health conditions. The condition can vary in severity, with some individuals experiencing more significant weight gain and associated health issues than others.