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

January 7, 2026 updated by: Prof. Dr. Martin Wabitsch
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Not yet recruiting
        • Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
        • Contact:
  • Germany
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
        • Contact:
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
        • Contact:
      • Ulm, Germany, 89075
        • Recruiting
        • Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
        • Contact:
        • Contact:
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Not yet recruiting
        • University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
        • Contact:
  • Spain
      • Madrid, Spain, 28009
        • Not yet recruiting
        • Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
        • Contact:
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Not yet recruiting
        • Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥12 to <21 years diagnosed with monogenic obesity, who agreed on treatment with semaglutide, are eligible for study participation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with biallelic variants in the LEPR, PCSK1, POMC, and MC4R gene
Drug: 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
Drug: 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
Drug: 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
Drug: 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 MC4R gene
Drug: 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
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68.
Time Frame: 68 weeks
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.
68 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoints for Weight and Health Parameters
Time Frame: 68 weeks
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.
68 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Martin Wabitsch

Collaborators

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Estimated)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1307-1203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to participant confidentiality requirements under GDPR regulations, IPD will not be shared. The study design also limits data sharing at this stage

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Monogenic Obesity

Clinical Trials on Semaglutide (administered by PDS290 pen-injector)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe