E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesity Overweight |
Obesidad Sobrepeso |
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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 Overweight |
Acumulación excesiva o anormal de grasa en el cuerpo/Exceso en la proporción total de grasa en el cuerpo Sobrepeso |
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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.1.2 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 |
|
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 two-year 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. |
Comparar el efecto sobre el peso corporal durante dos años de semaglutida s.c. 2,4 mg una vez a la semana frente a un placebo de semaglutida como complemento de una dieta hipocalórica y del aumento de la actividad física en pacientes con sobrepeso u obesidad. |
|
E.2.2 | Secondary objectives of the trial |
1. To compare the two-year 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 - Glucose metabolism 2. To compare the one-year 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 3. To compare the two-year 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. |
1. Comparar el efecto durante dos años de semaglutida s.c. 2,4 mg una vez a la semana frente a un placebo de semaglutida como complemento de una dieta hipocalórica y del aumento de la actividad física en pacientes con sobrepeso u obesidad sobre las siguientes variables: -Factores de riesgo cardiovascular -Metabolismo de la glucosa 2. Comparar el efecto sobre el peso corporal durante un año de semaglutida s.c. 2,4 mg una vez a la semana frente a un placebo de semaglutida como complemento de una dieta hipocalórica y del aumento de la actividad física en pacientes con sobrepeso u obesidad. 3. Comparar la seguridad y la tolerabilidad durante dos años de semaglutida s.c. 2,4 mg una vez a la semana frente a un placebo de semaglutida como complemento de una dieta hipocalórica y del aumento de la actividad física en pacientes con sobrepeso u obesidad. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, age 18 years or older at the time of signing informed consent 2. Body mass index (BMI) equal to or above 30 kg/sqm or equal to or above 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 |
1. Pacientes de ambos sexos, de 18 años o más en el momento de la firma del consentimiento informado. 2. Índice de masa corporal (IMC) ≥ 30 kg/m2 o ≥ 27 kg/m2 y presencia de al menos una de las siguientes enfermedades concomitantes relacionadas con el peso (tratadas o sin tratar): hipertensión, dislipidemia, apnea obstructiva del sueño o enfermedad cardiovascular. 3. Antecedentes de al menos un intento fallido de hacer dieta para adelgazar. |
|
E.4 | Principal exclusion criteria |
1. HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening 2. A self-reported change in body weight above 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. Variación del peso corporal > 5 kg en los 90 días anteriores a la selección referida por el paciente, con independencia de lo registrado en la historia clínica. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints addressing the primary objective: 1. Change in body weight (%) 2. Subjects who achieve (yes/no): - Body weight reduction equal to or above 5% |
Los criterios de valoración principales que abordan el objetivo principal son los siguientes: 1. Variación del peso corporal entre el momento basal (semana 0) y la semana 104 (%). 2. Pacientes que después de 104 semanas consigan (sí/no): − Una disminución del peso corporal ≥ 5% con respecto al momento basal (semana 0). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. + 2. From baseline (week 0) to week 104 |
1. +2. Entre el momento basal (semana 0) y la semana 104. |
|
E.5.2 | Secondary end point(s) |
Confirmatory secondary endpoints: 1. Subjects who achieve (yes/no): - Body weight reduction equal to or above 10% from baseline (week 0) - Body weight reduction equal to or above 15% from baseline (week 0) 2. Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg) |
Criterio de valoración secundario confirmatorio 1. Pacientes que después de 104 semanas consigan (sí/no): −Una disminución del peso corporal ≥ 10% con respecto al momento basal (semana 0). −Una disminución del peso corporal ≥ 15% con respecto al momento basal (semana 0). 2. Variación de los siguientes parámetros entre el momento basal (semana 0) y la semana 104: −Perímetro de la cintura (cm). −Presión arterial sistólica (mm Hg). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. After 104 weeks 2. From baseline (week 0) to week 104 |
1. Después de 104 semanas 2. Entre el momento basal (semana 0) y la semana 104 |
|
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 |
Canada |
European Union |
United States |
|
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
|
LVLS |
UVUS (Última visita del ultimo sujeto) |
|
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 | 14 |
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 | 14 |