E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033307 |
E.1.2 | Term | Overweight |
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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 establish the efficacy of 3.0 mg liraglutide compared to liraglutide placebo in inducing and maintaining weight loss over 52 weeks • To investigate the long term efficacy of 3.0 mg liraglutide in delaying onset of type 2 diabetes in obese subjects and overweight subjects with co-morbidities diagnosed with pre-diabetes
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E.2.2 | Secondary objectives of the trial |
• To investigate the long term efficacy of 3.0 mg liraglutide versus liraglutide placebo on cardiovascular risk markers such as blood pressure, lipids, glucose parameters and the metabolic syndrome as well as effects on quality of life •Patient Reported Outcome (PRO) and Binge Eating Scale (BES) Safety objective: •To evaluate the safety and tolerability of liraglutide
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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 procedure that would not have been performed during the normal management of the subject) 2. Body Mass Index (BMI) ≥ 30.0 kg/m^2 or ≥ 27 kg/m^2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia according to ATP-III) 3. Stable body weight (less than 5 kg self-reported change during the previous 3 months) 4. Preceding failed dietary effort 5. Age ≥ 18 years
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E.4 | Principal exclusion criteria |
Key exclusion criteria: • Known type 1 or type 2 diabetes • HbA_1c ≥ 7 % or FPG ≥ 7 mmol/L • History of acute or chronic pancreatitis • Obesity induced by drug treatment • Use of approved weight lowering pharmacotherapy • Previous surgical treatment of obesity • History of major depressive disorder or suicide attempt • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
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E.5 End points |
E.5.1 | Primary end point(s) |
• Body weight (fasting) loss at 52 weeks • Proportion of subjects losing more than 5% of baseline body weight at 52 weeks • Proportion of subjects losing more than 10% of baseline body weight at 52 weeks • Onset of type 2 diabetes among subjects having pre-diabetes evaluated at 3 years
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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.8.3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 62 |
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 | Information not present in EudraCT |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |