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 |
Proporción de grasa acumulada en exceso o de manera anormal en relación a la grasa total corporal |
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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 reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period, on body weight. |
Comparar el efecto que tiene en el peso corporal la administración s.c. de 2,4 mg de semaglutida una vez por semana frente a un placebo de semaglutida como complemento de la dieta hipocalórica y del aumento de la actividad física en sujetos con sobrepeso u obesidad que alcancen la dosis objetivo de semaglutida durante el período de preinclusión. |
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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 reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period, on - cardiovascular risk factors - clinical outcome assessments 2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period. |
1.Comparar el efecto que tiene la administración s.c. de 2,4 mg de semaglutida una vez por semana frente a un placebo de semaglutida como complemento de la dieta hipocalórica y del aumento de la actividad física en sujetos con sobrepeso u obesidad que alcancen la dosis objetivo de semaglutida durante el período de preinclusión, en: • factores de riesgo cardiovascular; • evaluaciones de los resultados clínicos. Seguridad y tolerabilidad: desde la aleatorización (semana 20) hasta la semana 75. 2.Comparar la seguridad y tolerabilidad de la administración s.c. de 2,4 mg de semaglutida una vez por semana frente a un placebo de semaglutida como complemento de la dieta hipocalórica y del aumento de la actividad física en sujetos con sobrepeso u obesidad que alcancen la dosis objetivo de semaglutida durante el período de preinclusión. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, age ≥ 18 years at the time of signing informed consent 2. BMI ≥ 30 kg/sqm or ≥ 27 kg/sqm with the presence of at least one of the following weightrelated 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 |
1. Hombres y mujeres con ≥ 18 años de edad en el momento de la firma del consentimiento informado. 2. IMC ≥ 30 kg/m2 o ≥ 27 kg/m2 y presencia de al menos una de las siguientes comorbilidades asociadas al peso (tratadas o sin tratar): hipertensión, dislipidemia, apnea obstructiva del sueño o enfermedad cardiovascular. 3. El paciente refiere antecedentes de al menos un intento fallido de hacer dieta para perder peso. |
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E.4 | Principal exclusion criteria |
1. HbA1c ≥ 48 mmol/mol (6.5%) as measured by 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 |
1. HbA1c ≥ 48 mmol/mol (6,5 %) determinada por el laboratorio central en la selección. 2. El paciente refiere una variación del peso corporal > 5 kg en los 90 días anteriores a la selección, con independencia de lo registrado en la historia clínica. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in body weight (%) |
Cambio en el peso corporal (%) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From randomisation (week 20) to week 68 |
Desde la aleatorización (semana 20) hasta la semana 68 |
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E.5.2 | Secondary end point(s) |
Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg) - Physical functioning score (SF-36) - Total score (Weight Related Sign and Symptom Measure (WRSSM)) |
Cambios en: • Perímetro de la cintura (cm) • Presión arterial sistólica (mm Hg) • Puntuación de la función física (SF-36) • Puntuación total (medición de signos y síntomas relacionados con el peso [WRSSM]) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From randomisation (week 20) to week 68 |
Desde la aleatorización (semana 20) hasta la semana 68 |
|
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 |
Tolerabilidad |
|
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 |
Israel |
South Africa |
Switzerland |
Ukraine |
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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 19 |