E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers, intended indications: obesity and dyslipidemia |
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E.1.1.1 | Medical condition in easily understood language |
Obesity and associated disorders such as impaired metabolism of lipids and glucose |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
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 evaluate the effect of Exenatide treatment on BAT activity and energy expenditure in healthy young subjects of South Asain and white Caucasian descent |
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E.2.2 | Secondary objectives of the trial |
To validate the MRI scan as a novel technique for measuring BAT |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Dutch South Asian or white Caucasian male, 18-30 years - BMI ≥ 18 and ≤ 25 kg/m2 - Good general health
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E.4 | Principal exclusion criteria |
- BMI > 25 kg/m2 or < 18 kg/m2 - Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers) - Any significant chronic disease - Renal, hepatic or endocrine disease - Smoking - Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study - Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year - Contraindications for undergoing an MRI scan: - Presence of non-MR safe metal implants or objects in the body. - Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable hearing aid, large recent tattoos. - Claustrophobia - Tinnitus or hyperacusis |
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E.5 End points |
E.5.1 | Primary end point(s) |
BAT volume and activity measured by 18F-FDG PET-CT scan and MRI scan |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 12 weeks of Exenatide treatment |
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E.5.2 | Secondary end point(s) |
- Fasted thermoneutral and cold-induced REE by indirect calorimetrie - Body weight and fat mass measured by BIA measurement - Fasting serum markers for glucose metabolism (glucose, insulin) - Fasting serum markers for lipid metabolism (total cholesterol, HDL-C, LDL-C, triglycerides, free fatty acids) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 12 weeks of Exenatide treatment |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Open-label single arm study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |