Once-weekly semaglutide for weight loss in adolescents with monogenic obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-interventional observational study follows adolescents with genetically confirmed monogenic obesity who are prescribed once-weekly subcutaneous semaglutide 2.4 mg as part of routine clinical care. Participants receive the drug alongside standard advice on calorie reduction and increased physical activity, and are followed for 68 weeks with measurements taken for weight, hunger, body composition, depression, and quality of life. Secondary data include treatment compliance and routine safety and tolerability parameters collected in clinical practice. Sites include pediatric endocrinology centers in Paris, Berlin, and Leipzig, and no randomization or experimental dosing is performed because treatment is given according to usual care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.
2. Informed consent of the patient, their parents, or legally acceptable representative (LAR) of participant and adolescent assent, as age-appropriate.
3. Age at time of signing informed consent: ≥12 to \<21 years.
4. BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov)
5. Body weight of \>60 kg.
6. Diagnosis of monogenic obesity by a Clinical Laboratory Improvement Amendments (CLIA)/ College of American Pathologists (CAP)/International Organisation for Standardization (ISO) 1518-certified laboratory using ACMG criteria as pathogenic (P), likely pathogenic (LP) and variant of uncertain significance (VUS).

Exclusion Criteria:

1. Participation in any interventional clinical trials at the time of enrolment.
2. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
3. Hypersensitivity to the active substance or to any of the excipients listed:

   * Disodium phosphate, dihydrate
   * Propylene glycol
   * Phenol
   * Hydrochloric acid (for pH adjustment)
   * Sodium hydroxide (for pH adjustment)
   * Water for injection
4. The safety and efficacy of Wegovy have not been investigated in patients:

   * treated with other products for weight management,
   * with type 1 diabetes,
   * with severe renal impairment (see section 4.2),
   * with severe hepatic impairment (see section 4.2),
   * with congestive heart failure New York Heart Association (NYHA) class IV. Use in these patients is not recommended

Where it's running

• Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
  Ulm, Germany Recruiting
• 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
• 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

Study contacts

• Study coordinator: Martin Wabitsch, Prof. Dr.
• Email: martin.wabitsch@uniklinik-ulm.de
• Phone: +4973150057401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mibavademab for obesity caused by leptin (LEP) gene mutations in children, adolescents, and adults

  This trial will try mibavademab in children, adolescents, and adults with leptin gene–related obesity to help control body weight and check safety.

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• Evaluating WEGOVY treatment for adults with genetic obesity

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.