Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Saxenda®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Liraglutide
CAS Number: 204656-20-2
Other descriptive name: LIRAGLUTIDE
Concentration unit: mg/l milligram(s)/litr
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - Cardiovascular risk factors - Glucose metabolism 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Effect endpoints 1. Relative change in body weight 2. Change in BMI standard deviation score WHO.int) 3. Subjects achieving greater than or equal to 5 percent (%) reduction of BMI 4. Subjects achieving greater than or equal to 10 percent (%) reduction of BMI 5. BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) 6. Change in waist circumference 7. Change in systolic blood pressure 8. Change in diastolic blood pressure 9. Change in glycated haemoglobin (HbA1c) - Safety endpoints 10. Treatment emergent adverse events (TEAEs) 11. Treatment emergent serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: - Effect endpoints 1.-9. From baseline (week 0) to week 56 - Safety endpoints 10.-11. From baseline (week 0) to week 82 | — |
Countries
Belgium, European Union, India, Israel, Malaysia, Mexico, Norway, Portugal, Russian Federation, Switzerland, United States
Contacts
Public ContactClinical Transparency (1452)
Novo Nordisk A/S
Outcome results
None listed