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NCT07302802Recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Jan 2026

Brief summary (registry, in English)

This observational study aims to assess the effect of once-weekly s.c. semaglutide 2.4 mg as an adjunct to a calorie-reduced diet and increased physical activity on weight loss, change in hunger, body composition, depression, and quality of life after 68 weeks of treatment in adolescents diagnosed with monogenic obesity in routine clinical care.

Status (registry)
Recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
10 Dec 2025
Start date
1 Dec 2025
Primary completion date
30 Jun 2028
Lead sponsor
Prof. Dr. Martin Wabitsch
Diseases
Obesity
NCT number
NCT07302802

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 1 Dec 2025 to the primary completion date, 30 Jun 2028
  • 7 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Lab values

  • 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

Other

  • Participation in any interventional clinical trials at the time of enrolment.
  • Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)

Who the study is looking for

  • Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.
  • Informed consent of the patient, their parents, or legally acceptable representative (LAR) of participant and adolescent assent, as age-appropriate.
  • Age at time of signing informed consent: ≥12 to \<21 years.
  • BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov)
  • Body weight of \>60 kg.
  • 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).

Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyNot yet recruiting
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
Coordinator of this site? Confirm its status
UlmGermanyRecruiting
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
Coordinator of this site? Confirm its status
CambridgeUnited KingdomNot yet recruiting
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
Coordinator of this site? Confirm its status
RotterdamNetherlandsNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.