A research study on how well liraglutide works in children with obesity

Phase 1

Conditions: MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Obesity

Registration Number: EUCTR2020-000546-34-NO

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 78

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
- Body Mass Index (BMI) greater than 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:
Haemoglobin A1c (glycated haemoglobin (HbA1c)) less than or equal to 10.0% (86 mmol/mol) as measured by central laboratory at screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 78
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- A self-reported (or by parent(s)/legally acceptable representative (LAR) where applicable) change in body weight greater than 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of liraglutide 3.0 mg administered subcutaneously (s.c., under the skin) once daily versus placebo on weight management in children aged 6 to below 12 years with obesity;Secondary Objective: 1. To compare the effect of liraglutide 3.0 mg administered subcutaneously (s.c., under the skin)once daily versus placebo in children aged 6 to below 12 years with obesity on:<br>- Cardiovascular risk factors <br>- Glucose metabolism<br>2. To evaluate the safety and tolerability of liraglutide 3.0 mg administered subcutaneously (s.c., under the skin) once daily versus placebo in children aged 6 to below 12 years with obesity;Primary end point(s): Relative change in Body Mass Index (BMI);Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 56

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Effect endpoints<br>1. Relative change in body weight<br>2. Change in BMI standard deviation score WHO.int) <br>3. Subjects achieving greater than or equal to 5 percent (%) reduction of BMI<br>4. Subjects achieving greater than or equal to 10 percent (%) reduction of BMI<br>5. BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)<br>6. Change in waist circumference<br>7. Change in systolic blood pressure<br>8. Change in diastolic blood pressure<br>9. Change in glycated haemoglobin (HbA1c)<br><br>- Safety endpoints<br>10. Treatment emergent adverse events (TEAEs)<br>11. Treatment emergent serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: - Effect endpoints<br>1.-9. From baseline (week 0) to week 56<br><br>- Safety endpoints<br>10.-11. From baseline (week 0) to week 82

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