Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
6–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, aged 6 to below 12 years at the time of signing informed consent
Tanner stage 1-5 pubertal development at the time of signing informed consent
BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov)
History of failing to lose sufficient weight with lifestyle modification as judged by the investigator
For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition:
\- Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening
You may not be if
A self-reported (or by parent(s)/LAR (legally acceptable representative) where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Treatment with any medication for the indication of obesity within the past 90 days before screening
Type 1 diabetes
Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
