E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Abnormal or excessive body fat accumulation/excess proportion of total body fat |
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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 | 19.0 |
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 |
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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 assess and compare the dose-response of five doses of once-daily semaglutide versus placebo in inducing and maintaining weight loss after 52 weeks in obese subjects without diabetes mellitus |
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E.2.2 | Secondary objectives of the trial |
1. To compare the effect of once-daily semaglutide versus once-daily liraglutide 3.0 mg in inducing and maintaining weight loss after 52 weeks in obese subjects without diabetes mellitus
2. To compare the effects of once-daily semaglutide to placebo and once-daily liraglutide 3.0 mg on:
– Glucose metabolism parameters |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2. Male or female, age ≥ 18 years at the time of signing inform consent
3. Body mass index (BMI) ≥ 30.0 kg/m^2 at the screening visit
4. At least one unsuccessful weight loss attempt per investigator judgement |
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E.4 | Principal exclusion criteria |
1. A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
2. Treatment with glucose lowering agent(s) within 90 days before screening
3. Screening calcitonin ≥ 50 ng/L (pg/mL)
4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
5. History of pancreatitis (acute or chronic)
6. Obesity induced by endocrine disorders (e.g. Cushing Syndrome)
7.Treatment with any medication within 90 days before screening that based on investigator’s judgement may cause significant weight change
8. Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed > 1 year before screening is allowed)
9. History of major depressive disorder within 2 years before randomisation
10. Any lifetime history of a suicidal attempt
11. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Relative change from baseline in body weight (%) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion (%) of subjects with weight loss of ≥ 5% of baseline body weight
2. Proportion (%) of subjects with weight loss of ≥ 10% of baseline body weight
Change in other parameters of weight loss:
3. Body weight (kg)
Change in glucose metabolism parameters:
4. Glycosylated haemoglobin (HbA1c)
5. Fasting plasma glucose (FPG) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 + 2: At 52 weeks
3 + 4 + 5: From baseline to 52 weeks |
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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 | Yes |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Stratified according to sex |
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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 | No |
E.8.2.4 | Number of treatment arms in the trial | 16 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
European Union |
Israel |
Russian Federation |
United States |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 19 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 19 |