E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of the study is to investigate if liraglutide (Saxenda) increases plasma levels of the two pancreatic enzymes: amylase and lipase, in overweight non-diabetic subjects, and to correlate such changes with changes of the pancreas (volumen estimated by PET-MR) |
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E.1.1.1 | Medical condition in easily understood language |
We wish to investigate if liraglutide (Saxenda) increases the blood levels of the two digestive enzymes: amylase and lipase, and further to see if such changes are connected with a bigger pancreas |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053880 |
E.1.2 | Term | Blood pancreatic amylase increased |
E.1.2 | System Organ Class | 100000004848 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067840 |
E.1.2 | Term | Hyperlipasemia |
E.1.2 | System Organ Class | 100000004861 |
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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 if liraglutide increases the volumen of the pancreas and as a consequence increases plasma levels of amylase and lipase |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
BMI higher or equal 26 and less than 50 kg/m2 Age over or equal 18 and under 65 years Men |
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E.4 | Principal exclusion criteria |
Abdominal waist over 60cm type 1 or type 2 diabetes Angina Pectoris, Heart Failure Statin treatment Kidney or liver disease Thyroid disease Inflammatory Bowel Disease Known Gastroparesis Cancer Obstructive or Restrictive lungdisease Psychiatric disease Previous gastric bypass operated Previously or currently acute pancreatitis Alchohol comsumption over the recommended amount by the authorities (Sundhedsstyrrelsen) Multiple Endocrine Neoplasia |
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E.5 End points |
E.5.1 | Primary end point(s) |
volumen (mL) of the pancreas determinted by magnet resonance |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Determined twice during the study. |
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E.5.2 | Secondary end point(s) |
Plasma concentrations of amylase and lipase weight changes Changes in glycemic control Plasma levels of glucagon, insulin and citrullin Levels of liraglutide Other imaging abnormalities in the pancreas flour-deoxyglucose uptake in the pancreas |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Two times during the study, for the plasma levels three times |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
The scope of the study is to investigate the effects of the gut hormone GLP-1 (using liraglutide) on the exocrine pancreas |
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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 | No |
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 |
Pancreatic volumen and enzymes before and after (2 weeks on 3mg dose) with Saxenda |
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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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |