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

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

This study tests whether once-weekly semaglutide 2.4 mg together with a reduced-calorie diet and increased activity helps adolescents with monogenic obesity lose weight, reduce hunger, and improve quality of life over 68 weeks.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 12 Years to 21 Years
• Sex: All
• Sponsor: University of Ulm (Academic / other)
• Locations: 7 sites (Paris and 6 other locations)
• Trial ID: NCT07302802 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adolescents aged ≥12 to <21 years who weigh >60 kg, have BMI ≥95th percentile, and have genetically confirmed monogenic obesity are the intended candidates for this protocol.

Not a fit: Patients without genetically confirmed monogenic obesity, those under 12 years or under 60 kg, pregnant females not using adequate contraception, or those enrolled in other interventional trials are unlikely to benefit from this observational program.

Why it matters

Potential benefit: If successful, this could provide an effective medical option to help adolescents with monogenic obesity lose weight and reduce hunger while improving quality of life.

How similar studies have performed: Semaglutide has produced substantial weight loss in adult and some adolescent obesity studies, but specific data in genetically defined monogenic obesity are limited, so this application remains relatively novel.

Eligibility criteria

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 this trial is running

Paris and 6 other locations

• 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)

Study contacts

• Study coordinator: Martin Wabitsch, Prof. Dr.

Conditions Monogenic Obesity; semaglutide; monogenic obesity