RecruitingOBSERVATIONAL

Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice

This clinical study aims to understand how a weekly injection called semaglutide helps young people aged 12 to 21 with a genetic form of obesity. It's a real-world study, meaning patients will receive the treatment as part of their normal care, alongside advice on diet and exercise. Over 68 weeks, researchers will carefully observe how semaglutide affects weight loss, changes in hunger, body measurements, and even mood and quality of life. They will also check if patients can easily stick to the treatment and if it's generally well-tolerated. The goal is to see if this treatment can make a meaningful difference for teenagers struggling with this specific type of obesity.

At a glance

Status

Recruiting

Sponsor

Prof. Dr. Martin Wabitsch

Enrolment target

Start

01 Dec 2025

Estimated completion

01 Dec 2028

Monogenic Obesity

What is this study about?

This study is looking at a medicine called semaglutide, which is given as a once-weekly injection. It's for young people aged 12 to 21 who have a specific kind of obesity called 'monogenic obesity'. This means their obesity is caused by a change in their genes. The study wants to see how well semaglutide works when used in everyday medical care, alongside healthy eating and being more active.

The main aim is to see how much weight young people lose over about 16 months (68 weeks) while using semaglutide. But it's not just about weight; the study also wants to understand other important things. This includes how semaglutide affects feelings of hunger, changes in body shape, and even how it influences mood and general happiness. They will also be checking if the medicine is easy to use and if people stick with it.

In simple terms, this study will help doctors and patients understand if this medicine can be a good option for teenagers with monogenic obesity, helping them manage their weight and improve their overall health and well-being. It's an 'observational study', which means the researchers are watching what happens in real life rather than setting up strict rules for treatment.

Key takeaways

Study for 12-21 year olds with genetic obesity.
Observing weekly semaglutide in real-world use.
Measuring weight loss, hunger, mood, and quality of life.
Lasts about 16 months (68 weeks).
No extra treatments or visits needed for the study.
Helps understand treatment's impact on this specific group.

Who may be eligible?

This study is looking for young people aged 12 to younger than 21. You would need to have been diagnosed with a specific type of obesity called 'monogenic obesity', which means your obesity is caused by a genetic reason. Your body weight must be over 60 kg, and your Body Mass Index (BMI) should be at or above the 95th percentile for your age and sex, according to standard growth charts. You also need to be already using semaglutide as prescribed by your doctor as part of your regular care.

There are some reasons why you might not be able to join. For example, if you are currently taking part in another clinical study where you are given an experimental treatment. Also, if you are a female who could become pregnant, you would need to be using reliable contraception. You cannot have a known allergy to semaglutide or any of its ingredients.

This study is also not recommended for people with certain serious health conditions, such as severe kidney or liver problems, uncontrolled heart failure, or type 1 diabetes. It's important that you and your parents or guardians understand all the details and agree to take part.

Quick self-check

Are you between 12 and younger than 21 years old?
Have you been diagnosed with 'monogenic obesity' by a specialist?
Do you weigh more than 60 kg?
Are you currently receiving semaglutide injections as part of your normal medical care?
Are you not allergic to semaglutide or any of its ingredients?
Do you NOT have serious kidney, liver, or heart problems, or Type 1 diabetes?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This is an 'observational' study, which means you would continue to receive your semaglutide injection weekly, as prescribed by your doctor, just like you normally would. You wouldn't be given new or different treatments specifically for the study. Instead, the study team would collect information about your health and how you're feeling during your regular check-ups over 68 weeks (about 16 months).

This could include measures like your weight, body composition (how much muscle and fat you have), and discussions about your hunger levels, mood (like any feelings of sadness or depression), and how you feel about your overall quality of life. They will also look at how well you are staying with your treatment. You wouldn't need extra visits just for the study, as data would be collected from your existing appointments.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of how semaglutide helps teenagers with monogenic obesity, which could help future patients. You would also receive regular medical care and monitoring. As this is an observational study, you are receiving the treatment as part of your standard care, so the risks are generally those associated with the semaglutide medication itself, which your doctor would have already discussed with you. Common side effects can include nausea, vomiting, diarrhoea, or constipation. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
Paris, France· Not yet recruiting
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
Berlin, Germany· Not yet recruiting
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
Leipzig, Germany· Not yet recruiting
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
Ulm, Germany· Recruiting
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
Rotterdam, Netherlands· Not yet recruiting
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
Madrid, Spain· Not yet recruiting
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
Cambridge, United Kingdom· Not yet recruiting

Common questions

What is 'monogenic obesity'?

It's a type of obesity caused by a specific change in a person's genes, making it different from more common types of obesity.

What is semaglutide?

It's a medicine given as a weekly injection that helps to reduce appetite and improve blood sugar control, leading to weight loss.

How long will the study last?

The study will follow participants for 68 weeks, which is about 16 months.

Will I have to take extra medicine?

No, you'll continue with your semaglutide treatment as prescribed by your doctor; no extra medicines are given for the study.

Are there any extra doctor visits needed for this study?

No, information for the study will be collected during your regular doctor's appointments.

How to find out more

Martin Wabitsch, Prof. Dr.

martin.wabitsch@uniklinik-ulm.de +4973150057401 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.