At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Semaglutide (administered by PDS290 pen-injector) (drug)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- Semaglutide (administered by PDS290 pen-injector) — drug: Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how well a once-weekly injection of a medicine called semaglutide helps young people aged 12 to under 21 lose weight. It is for young people with 'monogenic obesity', which means obesity caused by a change in a single gene, confirmed by a certified laboratory test. The study follows treatment given in normal clinical practice.
Who can take part
- Aged 12 to under 21 years at the time of agreeing to take part
- Body mass index (BMI, a measure of weight for height) at or above the 95th percentile for their age and sex
- Body weight over 60 kg
- A diagnosis of monogenic obesity from a certified laboratory, using standard genetics criteria
- Being treated with semaglutide as prescribed in routine care, following the medicine's approved product information
- Agreement (consent) from the patient, parent, or legal representative, and the young person's own agreement where appropriate
Who may not be able to
- Taking part in another interventional clinical trial at the time of joining
- Females who could become pregnant and are not using adequate contraception (as required by local law or practice)
- Allergy or bad reaction to semaglutide or any of its ingredients, including disodium phosphate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide, or water for injection
- Currently using other products for weight management
- Type 1 diabetes
- Severe kidney problems
- Severe liver problems
- Severe heart failure (New York Heart Association (NYHA) class IV, meaning symptoms even at rest)
What taking part involves
- • A once-weekly injection of semaglutide under the skin, as prescribed in routine clinical practice
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 12 Years to 21 Years
- Who
- All
- Number of participants
- 70
- Started
- 2025-12-01
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for monogenic obesity
- • Clinical study - 70 participants
- • This observational study aims to assess the effect of once-weekly s
Who can take part?
- • Ages 12 Years to 21 Years
- • Diagnosed with monogenic obesity
Where?
- • Cambridge - Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years - 21 Years
- Who can join: All genders
What the study is looking for
- ✓Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.
- ✓agreement to take part of the patient, their parents, or legally acceptable representative (LAR) of participant and...
- ✓Age at time of signing agreement to take part: ≥12 to \<21 years.
- ✓BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov)
- ✓Body weight of \>60 kg.
Who cannot take part
- ✗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...
- ✗Hypersensitivity to the active substance or to any of the excipients listed:
- ✗Disodium phosphate, dihydrate
- ✗Propylene glycol
See the full criteria
Where Is This Study? (1 UK site)
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
Cambridge CB2 0QQ, United Kingdom
How to Get in Touch
Martin Wabitsch, Prof. Dr.
Sponsor contactCONTACT
Stefanie Zorn, Dr.
Sponsor contactCONTACT