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 | 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 |
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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 compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight |
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E.2.2 | Secondary objectives of the trial |
1. To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on:
- Cardiovascular risk factors
- Clinical Outcome Assessments (COAs)
2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main phase:
1. Male or female, age ≥ 18 years at the time of signing informed consent
2. Body mass index (BMI) ≥ 30 kg/sqm or ≥ 27 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
3. History of at least one self-reported unsuccessful dietary effort to lose body weight
Extension phase:
1. Informed consent for the extension phase obtained before any trial related activities for the extension phase
2. On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo |
|
E.4 | Principal exclusion criteria |
Main phase:
1. HbA1C ≥ 48 mmol/mol (6.5%) as measured by the central laboratory at screening
2. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Extension phase:
1. Female who is pregnant or intends to become pregnant during the extension phase
2. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s compliance with the extension of the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change in body weight (%)
2. Subjects who achieve body weight reduction ≥ 5% (yes/no) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. From baseline at week 0 to week 68
2. After 68 weeks from baseline at week 0 |
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E.5.2 | Secondary end point(s) |
1. Subjects who achieve (yes/no):
- Body weight reduction ≥ 10%
- Body weight reduction ≥ 15%
2. Change in:
- Waist circumference (cm)
- Systolic blood pressure (mmHg)
- Physical functioning score (SF-36)
- Physical function domain (5-items) score (IWQoL-Lite for CT) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. After 68 weeks from baseline at week 0
2. From baseline at week 0 to week 68 |
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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 | 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 |
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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) | Yes |
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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 57 |
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 |
Argentina |
Canada |
European Union |
India |
Japan |
Mexico |
Russian Federation |
Taiwan |
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 | 10 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 14 |