Obesity MedDRA version: 19.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent 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. 2. Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation 3. BMI corresponding to =30 kg/m^2 for adults by international cut-off points and =the 95th percentile for age and sex (for diagnosis of obesity) 4. Stable body weight during the previous 90 days before screening V2 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pre-pubertal subjects (Tanner stage 1) at screening V2 2. Type 1 diabetes mellitus (T1DM) 3. Family or personal history of multiple endocrine neoplasia type 2 (MEN2) 4. Medullary thyroid carcinoma (MTC) 5. History of pancreatitis (acute or chronic) 6. Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes) 7. Treatment with medications within 90 days before screening V2 that, based on the investigator’s judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity) 8. Anti-diabetic treatment other than metformin 9. History of major depressive disorder within 2 years before screening V2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of liraglutide versus placebo on weight loss in adolescent subjects with obesity after 56 weeks of treatment; Secondary Objective: 1. To compare the efficacy of liraglutide versus placebo on glycaemic control and cardiovascular risk factors in adolescent subjects with obesity after 56 weeks of treatment 2. To compare the safety of liraglutide versus placebo in adolescent subjects with obesity after 56 weeks of treatment ;Primary end point(s): Change in body mass index (BMI) standard deviation score ;Timepoint(s) of evaluation of this end point: From baseline (randomisation) to 56 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percent of subjects achieving =5% reduction in baseline BMI 2. Percent of subjects achieving =10% reduction in baseline BMI - Change in: from baseline to 56 weeks 3. BMI 4. Body weight (kilogram [kg], pounds [lb] 5. Body weight (percent [%]) 6. Systolic and diastolic blood pressure 7. Glucose metabolism: glycosylated haemoglobin (HbA1c) and fasting plasma glucose 8. Number of treatment emergent adverse events ; Timepoint(s) of evaluation of this end point: 1.-2. At week 56 3.-8. From baseline to 56 weeks | — |
Countries
Belgium, European Union, Mexico, Russian Federation, Sweden, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed