Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Liraglutide: 6.0 mg/mL, 3.0 mL, for s.c. injection with FlexPen® for 56-weeks.
Control Intervention1: Placebo: placebo,3.0 mL with FlexPen® for 56-weeks.
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Informed consent of parents or LAR of subject and childassent,as age-appropriate,obtained before any trial-related activities.Trial-related acti-vites are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. a.The parents or LAR of the child must sign and date the Informed Consent Form according to local requirements.b The child must sign and date the Child Assent Form or provide oral assent according to local requirements2.Male or female,aged 6 to <12 years at the time of signing informedconsent3. Tanner stage 1-5 pubertal development at the time of signing informed consent.4.BMI =95th percentile5.History of failing to lose sufficient weight with lifestyle modification as judged by the investigator.For subjects with T2D at scree-ning the following inclusion criteria apply in addition to criteria 1-5:6.Subject with T2D treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening.7.HbA1c =10.0% (86 mmol/mol) as measured by central laboratory at screening
Exclusion criteria
Exclusion criteria: Obesity related 1.A self-reported or by parents or LAR where applicable change in body weight >5 kg 11 lbs within 90 days before screening irrespective of medical records 2.Treatment with any medication for the indication of obesity within the past 90 days before screening 3.Uncontrolled thyroid disease at screening, in the opinion of the investigator 4.Subjects with secondary causes of obesity for example hypothalamic, monogenic or endocrine causes Mental health 5.History of major depressive disorder within 2 years before screening 6.Diagnosis of other severe psychiatric disorders e.g., schizophrenia, bipolar disorder 7.A lifetime history of suicidal attempt 8.Subjects with confirmed diagnosis of bulimia nervosa disorder General Safety 9.History or presence of pancreatitis acute or chronic 10.Calcitonin =50 ng/L 11.Personal or first degree relatives history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma 12.Type 1 diabetes 13.Impaired renal function defined as serum-creatinine >UNR for age in children unless renal function is proven normal by further assessments at the discretion of the investigator 14.History of malignant neoplasms within the past 5 years prior to the day of screening 15.Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator 16.Known or suspected abuse of alcohol or recreational drugs 17.Known or suspected hypersensitivity to trial products or related products 18.Previous participation in this trial. Participation is defined as signed informed consent 19.Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening 20.Other subjects from the same household participating in any liraglutide trial 21.Female who is of child-bearing potential and not using an adequate contraceptive method adequate contraceptive measure as required by local regulation or practice 22.Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol Glycaemia-related 23.Treatment with glucose-lowering agents within 90 days before screening except for metformin 24.Treatment with a GLP-1 receptor agonist within 180 days before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo on weight management in children aged 6 to 12 years with obesityTimepoint: 56 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo in children aged 6 to 12 years with obesity on: 1.Cardiovascular risk factors 2.Glucose metabolism To evaluate the safety and tolerability of liraglutide 3.0 mg s.c. once daily versus placebo in children aged 6 to 12 years with obesityTimepoint: 56 weeks | — |
Countries
Belgium, India, Israel, Malaysia, Mexico, Norway, Portugal, Russian Federation, Switzerland, United States of America
Contacts
Public ContactMaya Sharma
Novo Nordisk India private Ltd
Outcome results
None listed