E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Abnormal or excessive body fat accumulation/excess proportion of total body fat |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of liraglutide versus placebo on weight loss in adolescent subjects with obesity after 56 weeks of treatment |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 (<5 kg self-reported weight change)
5. History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject’s medical record
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in body mass index (BMI) standard deviation score |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline (randomisation) to 56 weeks |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.-2. At week 56
3.-8. From baseline to 56 weeks
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
European Union |
Mexico |
Russian Federation |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |