Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT07302802
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT07302802
Study Brief:
Protocol Section:
NCT07302802