Trial · Observational
RecruitingPhase not statedRegistry dataFrance, Germany, Netherlands, Spain, United Kingdom
1 trial · 1 ongoing
Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
NCT073028021 Dec 2025 to est. Dec 2028
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Other
Patients with biallelic variants in the LEPR, PCSK1, POMC, and MC4R gene
Other
Patients with monoallelic variants in the LEPR gene
Other
Patients with monoallelic variants in the PCSK1 gene
Other
Patients with monoallelic variants in the POMC gene
Other
Patients with monoallelic variants in the MC4R gene
Other
Patients with monoallelic variants in the SH2B1 gene or with 16p11.2 deletions
Outcomes the sponsor listed as primary.
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.
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Case report · 2020
Iepsen et al. 2020Cell reports. Medicinecited by 28
PMID 33205056PMC7659505DOI 10.1016/j.xcrm.2020.100006PUB-33205056
1 study on this page
PubMed tag: none · 2021
Welling et al. 2021Clinical obesitycited by 20
PMID 34291582PMC9286843DOI 10.1111/cob.12481PUB-34291582
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