E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
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 maintenance of weight loss and health outcomes over 1 year with GLP-1 treatment (liraglutide), exercise treatment and the combination in obese persons who has obtained at least 5 % body weight loss by low calorie diet during 8 weeks. |
|
E.2.2 | Secondary objectives of the trial |
Changes in (1) Body composition (2) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) (3) Meal related appetite response (4) Peak oxygen uptake and determination of daily physical activity (5) Systemic markers of immune-metabolism and oxidation (6) Endothelial function (7) Immuno-metabolic changes in the subcutaneous adipose tissue (8) Gene expression profile of circulating inflammatory cells (9) Bone health (10) Food preferences and subjective appetite sensation (11) Faecal bacterial composition (12) Plasma metabolomics and proteomics (13) Epigenetics of spermatozoa (14) Questionnaries (SF-36, TFEQ, IPAQ, G-SES, PSQI) (13) Use of medication (n, frequency). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
BMI > 32 and < 43 (kg/m2), age > 18 and < 65 years |
|
E.4 | Principal exclusion criteria |
• Patients diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l) • Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV) • Severe renal impairment (creatinine clearance (GFR) <30 mL/min) • Severe hepatic impairment • Inflammatory bowel disease • Diabetic gastroparesis • Cancer • Chronic obstructive lung disease • Psychiatric disease, a history of major depressive or other severe psychiatric disorders • The use of medications that cause clinically significant weight gain or loss • Previous bariatric surgery • A history of idiopathic acute pancreatitis • A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma • Osteoarthritis which is judged to be too severe to manage the exercise programme. As intended per study design the intervention will include a 5% weight loss prior to randomization, thus it is expected that possible participants with mild form of osteoarthritis will be able to manage exercise prescriptions. • Pregnancy, expecting pregnancy or breast feeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice). Adequate contraception must be used throughout the study period and at least 65 hours after discontinuation of trial medication (65 hours corresponds to 5 times the half-life of Saxenda). Allergy to any of the ingredients/excipients. • Allergy to any of the ingredients/excipients of the study medication: liraglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide • Regular exercise training at high intensity (e.g. spinning) >2 hours per week.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Changes in (1) Body composition (2) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) (3) Meal related appetite response (4) Peak oxygen uptake and determination of daily physical activity (5) Systemic markers of immune-metabolism and oxidation (6) Endothelial function (7) Immuno-metabolic changes in the subcutaneous adipose tissue (8) Gene expression profile of circulating inflammatory cells (9) Bone health (10) Food preferences and subjective appetite sensation (11) Faecal bacterial composition (12) Plasma metabolomics and proteomics (13) Epigenetics of spermatozoa (14) Questionnaries (SF-36, TFEQ, IPAQ, G-SES, PSQI) (13) Use of medication (n, frequency). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 4 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |