Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
NCT ID: NCT07302802
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
70 participants
OBSERVATIONAL
2025-12-01
2028-12-31
Brief Summary
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Detailed Description
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The secondary objectives of this prospective, non-interventional observation are to evaluate treatment compliance and to assess the influence of once-weekly s.c. semaglutide 2.4 mg in clinical practice on hunger score, body mass parameters, body composition, and depression score after 68 weeks of treatment in adolescents diagnosed with monogenic obesity. In addition, we will document the known parameters of safety and tolerability to determine safety and tolerability in clinical practice.
The exploratory objective of this prospective, non-interventional observation is to assess user satisfaction by measuring change in subjective hunger score, quality of life, and perceptions and attitudes regarding treatment with semaglutide in adolescents diagnosed with monogenic obesity treated in routine clinical practice with once-weekly s.c. semaglutide 2.4 mg after 68 weeks of treatment.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with monoallelic variants in the MC4R gene
Semaglutide (administered by PDS290 pen-injector)
Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Patients with monoallelic variants in the SH2B1 gene or with 16p11.2 deletions
Semaglutide (administered by PDS290 pen-injector)
Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Patients with biallelic variants in the LEPR, PCSK1, POMC, and MC4R gene
Semaglutide (administered by PDS290 pen-injector)
Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Patients with monoallelic variants in the LEPR gene
Semaglutide (administered by PDS290 pen-injector)
Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Patients with monoallelic variants in the PCSK1 gene
Semaglutide (administered by PDS290 pen-injector)
Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Patients with monoallelic variants in the POMC gene
Semaglutide (administered by PDS290 pen-injector)
Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Interventions
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Semaglutide (administered by PDS290 pen-injector)
Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
21 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Prof. Dr. Martin Wabitsch
OTHER
Responsible Party
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Prof. Dr. Martin Wabitsch
Principal Investigator
Locations
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Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
Paris, , France
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
Berlin, , Germany
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
Leipzig, , Germany
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
Ulm, , Germany
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
Rotterdam, , Netherlands
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
Madrid, , Spain
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Béatrice Dubern, Prof. Dr.
Role: primary
Peter Kühnen, Prof. Dr.
Role: primary
Antje Körner, Prof. Dr.
Role: primary
Martin Wabitsch, Prof. Dr.
Role: primary
Stefanie Zorn, Dr.
Role: backup
Erica van den Akker, Prof. Dr.
Role: primary
Jesús Argente, Prof. Dr.
Role: primary
Sadaf Farooqi, Prof. Dr.
Role: primary
References
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Welling MS, de Groot CJ, Kleinendorst L, van der Voorn B, Burgerhart JS, van der Valk ES, van Haelst MM, van den Akker ELT, van Rossum EFC. Effects of glucagon-like peptide-1 analogue treatment in genetic obesity: A case series. Clin Obes. 2021 Dec;11(6):e12481. doi: 10.1111/cob.12481. Epub 2021 Jul 21.
Iepsen EW, Have CT, Veedfald S, Madsbad S, Holst JJ, Grarup N, Pedersen O, Brandslund I, Holm JC, Hansen T, Torekov SS. GLP-1 Receptor Agonist Treatment in Morbid Obesity and Type 2 Diabetes Due to Pathogenic Homozygous Melanocortin-4 Receptor Mutation: A Case Report. Cell Rep Med. 2020 Apr 21;1(1):100006. doi: 10.1016/j.xcrm.2020.100006. eCollection 2020 Apr 21.
Wabitsch M, Farooqi S, Fluck CE, Bratina N, Mallya UG, Stewart M, Garrison J, van den Akker E, Kuhnen P. Natural History of Obesity Due to POMC, PCSK1, and LEPR Deficiency and the Impact of Setmelanotide. J Endocr Soc. 2022 Apr 15;6(6):bvac057. doi: 10.1210/jendso/bvac057. eCollection 2022 Jun 1.
Courbage S, Poitou C, Le Beyec-Le Bihan J, Karsenty A, Lemale J, Pelloux V, Lacorte JM, Carel JC, Lecomte N, Storey C, De Filippo G, Coupaye M, Oppert JM, Tounian P, Clement K, Dubern B. Implication of Heterozygous Variants in Genes of the Leptin-Melanocortin Pathway in Severe Obesity. J Clin Endocrinol Metab. 2021 Sep 27;106(10):2991-3006. doi: 10.1210/clinem/dgab404.
Nordang GBN, Busk OL, Tveten K, Hanevik HI, Fell AKM, Hjelmesaeth J, Holla OL, Hertel JK. Next-generation sequencing of the monogenic obesity genes LEP, LEPR, MC4R, PCSK1 and POMC in a Norwegian cohort of patients with morbid obesity and normal weight controls. Mol Genet Metab. 2017 May;121(1):51-56. doi: 10.1016/j.ymgme.2017.03.007. Epub 2017 Mar 29.
Other Identifiers
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U1111-1307-1203
Identifier Type: -
Identifier Source: org_study_id