E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overweight Obesity |
Prekomjerna tjelesna težina Pretilost |
|
E.1.1.1 | Medical condition in easily understood language |
Overweight Obesity |
Prekomjerna tjelesna težina Pretilost |
|
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 | 24.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033307 |
E.1.2 | Term | Overweight |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
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 demonstrate that semaglutide subcutaneously (s.c) 2.4 mg once-weekly lowers the incidence of major adverse cardiovascular events (MACE) versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity. |
Pokazati da supkutana primjena semaglutida u dozi od 2,4 mg jedanput na tjedan smanjuje rizik od MACE u usporedbi sa semaglutid placebom, oba u kombinaciji sa standardnim liječenjem, u osoba s ustanovljenom kardiovaskularnom bolešću i prekomjernom tjelesnom težinom ili pretilošću.
|
|
E.2.2 | Secondary objectives of the trial |
To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity with regards to mortality |
Usporedba učinka supkutane primjene semaglutida u dozi od 2,4 mg jedanput na tjedan naspram semagluid placeba, oba u kombinaciji sa standardnim liječenjem, u osoba s ustanovljenom kardiovaskularnom bolešću i prekomjernom tjelesnom težinom ili pretilošću vezano uz mortalitet. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, age equal to or above 45 years at the time of signing informed consent 2. Body mass index (BMI) equal to or above 27 kg/sqm 3. Have established CV disease as evidenced by at least one of the following: - prior myocardial infarction - prior stroke (ischemic or haemorrhagic stroke) or - symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease |
1. Muškarci ili žene u dobi ≥ 45 godina u vrijeme potpisivanja Informiranog pristanka 2. Indeks tjelesne mase (ITM) ≥ 27 kg/m2 3. Ustanovljena kardiovaskularna bolest koju dokazuje barem jedno od sljedećeg: - preboljen infarkt miokarda - preboljen moždan udar (ishemijski ili hemoragijski) - simptomatska bolest perifernih arterija (BPA) koja se očituje intermitentnim klaudikacijama s pedobrahijalnim indeksom < 0,85 (u mirovanju), ili postupak periferne arterijske revaskularizacije, ili amputacija zbog ateroskleroze.
|
|
E.4 | Principal exclusion criteria |
1. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening 2. HbA1c equal to or above 48 mmol/mol (6.5 %) as measured by the central laboratory at screening 3. History of type 1 or type 2 diabetes (history of gestational diabetes is allowed) |
1. Bilo što od sljedećeg: infarkt miokarda, moždani udar, hospitalizacija zbog nestabilne angine pectoris ili prolazne ishemične atake u proteklih 60 dana prije dana probira 2. HbA1c ≥ 48 mmol/mol (6,5%) izmjeren u centralnom laboratoriju za vrijeme probira 3. Dijagnosticirana šećerna bolest tipa 1 ili tipa 2 u povijesti bolesti (dijagnoza gestacijske šećerne bolesti je dozvoljena)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time from randomisation to first occurrence of a composite endpoint consisting of: CV death, non-fatal myocardial infarction, or non-fatal stroke |
Vrijeme od randomizacije do prve pojave kompozitnog ishoda kojeg čine: smrt uzrokovana kardiovaskularnim događajem, infarkt miokarda bez smrtnog ishoda ili moždani udar bez smrtnog ishoda. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From randomisation to first occurrence of a composite endpoint |
Vrijeme od randomizacije do prve pojave kompozitnog ishoda.
|
|
E.5.2 | Secondary end point(s) |
1. Time from randomisation to CV death 2. Time from randomisation to all-cause death |
1. vrijeme od randomizacije do smrti uzrokovane kardiovaskularnim događajem 2. vrijeme od randomizacije do smrti bilo kojeg uzroka
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. + 2.: Time from randomisation to event |
1. + 2.: Vrijeme od randomizacije do događaja |
|
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 | 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) | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 292 |
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 |
Algeria |
Argentina |
Australia |
Brazil |
Canada |
Colombia |
India |
Israel |
Japan |
Malaysia |
Mexico |
South Africa |
Taiwan |
Thailand |
United States |
European Union |
Norway |
Russian Federation |
Serbia |
Turkey |
Ukraine |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |