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 | LLT |
E.1.2 | Classification code | 10029885 |
E.1.2 | Term | Obesity, unspecified |
E.1.2 | System Organ Class | 100000004861 |
|
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 |
A) To treat young adults with childhood-onset obesity, who have been resistant to structured lifestyle intervention (TCOC protocol), with the GLP-1 RA semaglutide (Wegovy®). B) To treat young adults with childhood-onset obesity, who have responded to the structured lifestyle intervention (TCOC protocol) and still have obesity, with the same GLP-1 RA, semaglutide (Wegovy®). C) To identify underlying mechanisms of lifestyle-untreatable versus treatable childhood-onset obesity.
|
|
E.2.2 | Secondary objectives of the trial |
Determine the effect of a GLP-1 receptor agonist on body composition and metabolic health in young adults with obesity |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age 18-28 years • Group A: BMI>30. Non-responders: No BMI SDS reduction (<0.1 BMI SDS) during TCOC protocol for more than one year and still have obesity (BMI>30). • Group B: BMI>30. Insufficient responders: BMI SDS reduction >0.25 BMI SDS during TCOC protocol for more than one year, but still have obesity (BMI>30). • Only baseline examination: Group C: BMI<30. Excellent responders: BMI SDS reduction >0.5 BMI SDS during TCOC protocol for more than one year and no longer have obesity (BMI<30).
The period from the initial treatment with TCOC protocol until inclusion in the study must be within 10 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 • Pregnancy, expecting pregnancy or breastfeeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Women with reproductive potential who are not using adequate contraceptive methods (combined oral contraceptive pill, progestin-only contraceptive pill, condoms, intrauterine device, injection, implant, or sterilization). 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 of the study medication: liraglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in BMI from before to after GLP-1 RA treatment in non-responders to TCOCT protocol compared to placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Body composition 2) Body weight 3) change in BMI from before to after GLP-1 RA treatment in insufficient responders to TCOCT protocol compared to placebo 4) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) 4) liver fat 5) weight loss induced bone loss 6) appetite regulation 7) systemic markers of immuno-metabolism 8) immuno-metabolic profile of adipose tissue 9) circulating inflammatory cells (PBMCs) 10) food preferences and appetite sensation 11) genetic risk scores 12) microbiota 13) metabolomics |
|
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
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 |