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 | 9.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
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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 investigate the efficacy of liraglutide to induce weight loss |
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E.2.2 | Secondary objectives of the trial |
•To establish the dose-response relationship of four dose levels of liraglutide and placebo on weight loss •To compare the weight lowering effect of liraglutide to orlistat To investigate the effect induced by liraglutide on: •Body composition •Cardiovascular risk factors •Glucose metabolism incl. β-cell function •Presence of the metabolic syndrome •Patient reported quality of life •To investigate the long term efficacy of liraglutide to induce and maintain weight loss
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Informed consent obtained prior to 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 and ≤ 40.0 kg/m2 3.Stable body weight (less than 5% self-reported change during the previous 3 months) 4.Age between 18 and 65 years (both inclusive) 5.Fasting plasma glucose < 7.0 mmol/L
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E.4 | Principal exclusion criteria |
1.Untreated thyroid disease defined as TSH values outside normal ranges or obesity induced by other known endocrinological disorders 2.Obesity induced by drug treatment (e.g. corticosteroids, tricyclic anti-depressants, atypical anti-psychotics) 3.Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to screening into this trial 4.Participation in a clinical study of weight control within the last 3 months prior to screening into this trial 5.Previous surgical treatment of obesity 6.Subjects with chronic malabsorption syndrome or cholestasis 7.Known type 1 or type 2 diabetes 8.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator 9.Impaired liver function, defined as ALAT ≥ 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) 10.Impaired renal function defined as serum-creatinine ≥ 135 µmol/L (≥ 1.5 mg/dL) for males and ≥ 120 µmol/L (≥ 1.4 mg/dL) for females (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) 11.Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the Investigator. (Please refer to Appendix C) 12.Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 13.Any clinically significant disease which in the Investigator’s opinion could interfere with the results of the trial 14.Cancer (past or present, except basal cell skin cancer or sqaumous cell skin cancer), which in the Investigator’s opinion could interfere with the results of the trial 15.Known or suspected allergy to trial product(s) or related product(s) 16.Previous participation in this trial (screening and treatment period) 17.Known or suspected abuse of alcohol or narcotics 18.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 19.Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) 20.The receipt of any investigational drug within four weeks prior to screening into this trial
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |