E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 in a FIRST PHASE of the study the effect on weight loss of the combination of fenofibrate 267 mg per day and metformin 1700 mg per day, on top of a moderate balanced calorie-deficit diet as compared to metformin alone 1700 mg per day and to placebo, in obese patients not diagnosed with type 2 diabetes mellitus. To investigate, in a SECOND PHASE of the study, the effect on weight-loss maintenance of the combination of fenofibrate 267 mg per day and metformin 1700 mg per day, as compared to placebo on top of an eucaloricdiet, in the sub-set of patients who responded to the study treatment and/or to the hypocaloric diet in terms of weight loss in first phase of the study (at least 5% weight loss). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Both genders, from 30 to 50 years old. Obese, with BMI > 30 kg/m2 and < 40kg/m2. Not previously included in the last 24 weeks in a intervention study (either a pharmacology one with an anti-obesity drug-already registered or in development-, or a lifestyle modification one with a Very Low Caloric Diet). In absence of previous diagnosis of T2DM, or with FPG levels less than 7.0 mmol/L at inclusion. With reliable method of contraception in female at child bearing potential and with negative pregnancy test (serum or urine B-HCG), at inclusion. Not currently treated or treated in the last 30 days with fibrate, a statin or with any glucose lowering agent, and without a clear indication for such therapy. With written informed consent. Criterion fo randomisation in the second phase: Weight loss responders, defined as with at least 5% weight loss in the first phase of the trial under hypocaloric diet and study treatment. |
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E.4 | Principal exclusion criteria |
Female at pre-menopause stage with menstrual irregularities. Known abnormal thyroid hormonen levels, or high thyroid stimulating hormone (TSH) level. Having stop smoking within the last 12 weeks. Included in the last 24 weeks in an obesity intervention study with anti-obesity drug or with a Very Low Caloric Diet. Plasma creatinine levels > 115 µmol/L in male and > 95 µmol/L in female. Known hypersensitivity to fibrates or metformin chlorhydrate. Treated with cyclosporin A, anti-vitamin K, cortico-streroids or protease inhibitors. Current chronic pancreatitis, or identifield risk or known history of acute pancreatitis or with TG level > 11.0 mmol/L (at risk of pancreatitis). Current chronic liver diseases, AST and/or ALT > 1.5 times the upper normal limit (UNL). Known cholelithiasis in absence of cholecystectomy. Past medical history of myositis, myopathy or rhabdomyolosis. Creatine phosphokinase (CK) > 3 times UNL. With any other severe pathology such as cancer or mental illness. |
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E.5 End points |
E.5.1 | Primary end point(s) |
FIRST PHASE: Weight loss at endpoint after 26 weeks of treatment: absolute change between endpoint and baseline. SECOND PHASE: Absolute variation of weight between the end of the first phase and the end of the study. |
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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 | Yes |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |