SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

Study Overview
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Brief Summary
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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 children will lose, and if there are any side effects. Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day. In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight. The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.

Official Title
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Effect and Safety of Liraglutide 3.0 mg on Weight Management in Children With Obesity Aged 6 to Below 12 Years: 56-week, Double-blind, Randomised, Placebo-controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide 3.0 mg<br>The treatment duration is 56 weeks and the follow-up period is 26 weeks. | Drug: Liraglutide<br>* The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. The dose will increase each week over 4 or 5 weeks until the final dose is reached.<br>|
| Placebo Comparator: Placebo<br>The treatment duration is 56 weeks and the follow-up period is 26 weeks. | Drug: Placebo<br>* The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in BMI (Body mass index) | Percent | From baseline (week 0) to week 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in body weight | Percent | From baseline (week 0) to week 56 | 
| Change in BMI standard deviation score (WHO.int) | Unitless | From baseline (week 0) to week 56 | 
| Subjects achieving above or equal to 5 percent reduction of BMI | Yes/no | From baseline (week 0) to week 56 | 
| Subjects achieving above or equal to 10 percent reduction of BMI | Yes/no | From baseline (week 0) to week 56 | 
| BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) | Percent point | From baseline (week 0) to week 56 | 
| Change in waist circumference | cm | From baseline (week 0) to week 56 | 
| Change in systolic blood pressure | mmHg | From baseline (week 0) to week 56 | 
| Change in diastolic blood pressure | mmHg | From baseline (week 0) to week 56 | 
| Change in HbA1c (glycated haemoglobin) | Percent point | From baseline (week 0) to week 56 | 
| Treatment emergent adverse events (TEAEs) | Number | From baseline (week 0) to week 82 | 
| Treatment emergent serious adverse events (SAEs | Number | From baseline (week 0) to week 82 |