E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overweight
Obesity |
Prekomjerna tjelesna težina
Pretilost
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E.1.1.1 | Medical condition in easily understood language |
Overweight
Obesity |
Prekomjerna tjelesna težina
Pretilost
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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 | 10033307 |
E.1.2 | Term | Overweight |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 subcutaneous once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity on weight management in adolescents (ages 12 to less than 18 years) with overweight or obesity. |
Usporedba učinka supkutane primjene semaglutida jednom tjedno u odnosu na placebo, oba kao dodatak dijeti sa smanjenim unosom kalorija i povećanoj fizičkoj aktivnosti, na kontrolu tjelesne težine u adolescenata (u dobi od 12 do <18 godina) s prekomjernom tjelesnom težinom ili pretilošću. |
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E.2.2 | Secondary objectives of the trial |
1. To compare the effect of semaglutide subcutaneous once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in adolescents (ages 12 to less than 18 years) with overweight or obesity on:
- Cardiovascular risk factors
- Glucose metabolism
2. To compare the safety and tolerability of semaglutide subcutaneous once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in adolescents with overweight or obesity |
1. Usporedba učinka supkutane primjene semaglutida jednom tjedno u odnosu na placebo, oba kao dodatak dijeti i povećanoj fizičkoj aktivnosti u adolescenata (u dobi od 12 do <18 godina) s prekomjernom tjelesnom težinom ili pretilošću, na:
• kardiovaskularne faktore rizika
• metabolizam glukoze
2. Usporedba sigurnosti primjene i podnošljivost supkutane primjene semaglutida jednom tjedno u odnosu na placebo, oba kao dodatak dijeti i povećanoj fizičkoj aktivnosti u adolescenata s prekomjernom tjelesnom težinom ili pretilošću
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate 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
- Male or female, ages 12 to less than 18 years at the time of signing informed consent
- BMI equal to or above 95th percentile (on gender and age-specific growth charts (CDC.gov)) OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with up to 1 weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes
- History of at least one self-reported unsuccessful dietary effort to lose weight
For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:
- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening |
- Potpisani Informirani pristanak od stane roditelja ili zakonskog zastupnika, skrbnika te samog djeteta, prije poduzimanja bilo kakvih aktivnosti vezanih uz ispitivanje, uključujući procjenu podobnosti ispitanika za sudjelovanje u ispitivanju
- Mladići ili djevojke u dobi od 12 do < 18 godina u vrijeme potpisivanja Informiranog pristanka
- Indeks tjelesne mase (ITM) ≥ 95-tog centila* ili ≥ 85-tog centila* s prisutnošću barem jednog ili više komorbiditeta povezanog s tjelesnom težinom (liječenog ili neliječenog): hipertenzija, dislipidemija, opstruktivna apneja ili šećerna bolest tipa 2
- Barem jedan neuspješni pokušaj držanja dijete radi smanjivanja tjelesne težine, u povijesti bolesti, prema navodu ispitanika
* Prema centilnim krivuljama indeksa tjelesne mase ovisno o dobi i spolu djeteta (CDC.gov)
Za ispitanike koji na posjeti probira imaju dijagnosticiranu šećernu bolest tipa 2, dodatni kriterij:
- HbA1c ≤10.0% mjereno u centralnom laboratoriju na dan probira
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E.4 | Principal exclusion criteria |
- Prepubertal subjects (Tanner stage 1)
- History of type 1 diabetes
- A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes)
- For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination |
- Ispitanici u predpubertalnom razdoblju ( faza 1 prema Tanner-u)
- Šećerna bolest tipa 1 u povijesti bolesti
- Prijavljeno smanjenje tjelesne mase više od 5 kg unutar 90 dana prije probira, od strane samog ispitanika (ili roditelja/zakonskog zastupnika, skrbnika)
- Ispitanici sa sekundarnim uzrocima pretilosti (npr. hipotamični, monogeni ili endokrinološki uzroci)
Za ispitanike koji imaju dijagnosticiranu šećernu bolest tipa 2, dodatni kriterij: Nekontrolirana i potencijalno nestabilna dijabetička retinopatija ili makulopatia. Potvrđena pregledom fundusa tijekom 90 dana prije probira. Farmakološka dilatacija fundusa je preporučena kao dijagnostički postupak, osim ukoliko se koristi digitalna slika fundusa kao ne-dilatacijska metoda.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in BMI from baseline |
Promjena ITM od početne vrijednosti |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 0 to week 68 |
Od 0.-tog do 68.-mog tjedna |
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E.5.2 | Secondary end point(s) |
Subjects achieving equal to or above 5% reduction of body weight from baseline (yes/no) |
Ispitanici koji su postigli ≥5% smanjenje tjelesne težine od početne vrijednosti (da / ne) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 0 to week 68 |
Od 0.-tog do 68.-mog tjedna |
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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 |
Tolerability |
Podnošljivost |
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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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 |
European Union |
Mexico |
Russian Federation |
United States |
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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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 21 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 21 |