Status:
ACTIVE_NOT_RECRUITING
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the chi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04775082
Start Date
March 4 2021
End Date
January 15 2027
Last Update
December 4 2025
Active Locations (31)
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1
TMC Hlthcr Clin Res Office
Tucson, Arizona, United States, 85712
2
Children's Hospital Colorado
Denver, Colorado, United States, 80045
3
Solaris Clinical Research
Meridian, Idaho, United States, 83646
4
Pennington Biom Res Ctr
Baton Rouge, Louisiana, United States, 70808