SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
- Conditions
- Obesity
- Registration Number
- NCT04775082
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria:<br><br> - Informed consent of parent(s) or legally acceptable representative of subject and<br> child assent, as age-appropriate, obtained before any trial-related activities.<br> Trial-related activities are any procedures that are carried out as part of the<br> trial, including activities to determine suitability for the trial<br><br> - Male or female, aged 6 to below 12 years at the time of signing informed consent<br><br> - Tanner stage 1-5 pubertal development at the time of signing informed consent<br><br> - BMI above or equal to 95th percentile, on gender and age-specific growth charts<br> (CDC.gov)<br><br> - History of failing to lose sufficient weight with lifestyle modification as judged<br> by the investigator<br><br>For subjects with type 2 diabetes at screening the following inclusion criterion apply in<br>addition:<br><br> - Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by<br> central laboratory at screening<br><br>Exclusion Criteria:<br><br> - A self-reported (or by parent(s)/LAR (legally acceptable representative) where<br> applicable) change in body weight above 5 kg (11 lbs) within 90 days before<br> screening irrespective of medical records<br><br> - Treatment with any medication for the indication of obesity within the past 90 days<br> before screening<br><br> - Type 1 diabetes<br><br> - Subjects with secondary causes of obesity (for example hypothalamic, monogenic or<br> endocrine causes)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative change in BMI (Body mass index)
- Secondary Outcome Measures
Name Time Method Relative change in body weight;Change in BMI standard deviation score (WHO.int);Subjects achieving above or equal to 5 percent reduction of BMI;Subjects achieving above or equal to 10 percent reduction of BMI;BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov);Change in waist circumference;Change in systolic blood pressure;Change in diastolic blood pressure;Change in HbA1c (glycated haemoglobin);Treatment emergent adverse events (TEAEs);Treatment emergent serious adverse events (SAEs