Monogenic ObesityNCT07302802
Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
An observational study of Monogenic Obesity, run by Prof. Dr. Martin Wabitsch at 7 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Monogenic Obesity
- What is being tested?
- Semaglutide (administered by PDS290 pen-injector)
- How many people
- 70 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 1 Dec 2025to Dec 2028
- How long will I take part?
- 68 Weeks
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged ≥12 to <21 years diagnosed with monogenic obesity, who agreed on treatment with semaglutide, are eligible for study participation.
Who may be able to join
- 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).
Who cannot join
- 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)
- Hypersensitivity to the active substance or to any of the excipients listed:
- Disodium phosphate, dihydrate
- Propylene glycol
- Phenol
Show all 15Show fewer
- Hydrochloric acid (for pH adjustment)
- Sodium hydroxide (for pH adjustment)
- Water for injection
- 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
Trial locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
Berlin, 13353
Peter Kühnen, Prof. Dr., peter.kuehnen@charite.de
- Not yet recruiting
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
Leipzig, 04103
Antje Körner, Prof. Dr., antje.koerner@medizin.uni-leipzig.de
- Recruiting
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
Ulm, 89075
Martin Wabitsch, Prof. Dr., +4973150057401, martin.wabitsch@uniklinik-ulm.de
Stefanie Zorn, Dr., +4973150057457, stefanie.zorn@uniklinik-ulm.de
France1 site, 1 recruiting
- Not yet recruiting
Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
Paris
Béatrice Dubern, Prof. Dr., beatrice.dubern@aphp.fr
Netherlands1 site, 1 recruiting
- Not yet recruiting
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
Rotterdam, 3015 GD
Erica van den Akker, Prof. Dr., e.l.t.vandenakker@erasmusmc.nl
Spain1 site, 1 recruiting
- Not yet recruiting
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
Madrid, 28009
Jesús Argente, Prof. Dr., jesus.argente@fundacionendo.org
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
Cambridge, CB2 0QQ
Sadaf Farooqi, Prof. Dr., isf20@medschl.cam.ac.uk
About this study
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.
Read the detailed description
The primary objective of this prospective, non-interventional observational study is to evaluate the effect of once-weekly s.c. semaglutide 2.4 mg in routine clinical care as an adjunct to a calorie-reduced diet and increased physical activity on weight loss after 68 weeks of treatment in adolescents diagnosed with monogenic obesity.
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
- Monogenic Obesity
- Being tested
- Semaglutide (administered by PDS290 pen-injector)
- Keywords
- semaglutide, monogenic obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (administered by PDS290 pen-injector)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with biallelic variants in the LEPR, PCSK1, POMC, and MC4R gene | Not described Receives: Drug: Semaglutide (administered by PDS290 pen-injector) | |
| Patients with monoallelic variants in the LEPR gene | Not described Receives: Drug: Semaglutide (administered by PDS290 pen-injector) | |
| Patients with monoallelic variants in the PCSK1 gene | Not described Receives: Drug: Semaglutide (administered by PDS290 pen-injector) | |
| Patients with monoallelic variants in the POMC gene | Not described Receives: Drug: Semaglutide (administered by PDS290 pen-injector) | |
| Patients with monoallelic variants in the MC4R gene | Not described Receives: Drug: Semaglutide (administered by PDS290 pen-injector) | |
| Patients with monoallelic variants in the SH2B1 gene or with 16p11.2 deletions | Not described Receives: Drug: Semaglutide (administered by PDS290 pen-injector) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68.
The study evaluates the effect of once-weekly subcutaneous (s.c.) semaglutide 2.4 mg administered as an adjunct to a calorie-reduced diet and increased physical activity in adolescents diagnosed with monogenic obesity. This measure focuses on weight loss effectiveness, with the goal of assessing the impact of the treatment on BMI reduction in a real-world clinical setting after 68 weeks of treatment. The study aims to provide insight into the potential of semaglutide in managing weight in this specific patient population.
Measured: 68 weeks
Secondary outcomes (1)
Secondary Endpoints for Weight and Health Parameters
The secondary endpoints of this study focus on changes in health outcomes over 68 weeks. These include body weight and BMI, measured as percentages or in kg and kg/m², with specific thresholds (e.g., 95th percentile) for age- and sex-specific BMI. Blood pressure (systolic and diastolic) is recorded in mmHg. Cholesterol levels (total, HDL, LDL, triglycerides) are assessed in mg/dL to evaluate cardiovascular risk. HbA1c (percentage), fasting glucose (mg/dL), and insulin (pmol/L) are monitored for metabolic health. ALT (IU/L) measures liver function. Changes in fat and lean mass are evaluated by DXA (kg). Weight and BMI velocity are measured in percentage points. The proportion of participants achieving ≥5% and ≥15% BMI reduction is also reported, offering insight into the treatment's effectiveness on weight and metabolic health.
Measured: 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Dec 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Monogenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 68 Weeks
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Martin Wabitsch
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Prof. Dr. Martin Wabitsch, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302802
- Sponsor's protocol ID
- U1111-1307-1203
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to participant confidentiality requirements under GDPR regulations, IPD will not be shared. The study design also limits data sharing at this stage
Publications
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.
PubMed 34291582Iepsen 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.
PubMed 33205056Wabitsch 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.
PubMed 35528826Courbage 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.
PubMed 34097736Nordang 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.
PubMed 28377240