E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overweight and obese individuals at high risk of chronic kidney disease progression. |
Pacientes con sobrepeso/obesidad con alto riesgo de progresion de la enfermedad renal crónica |
|
E.1.1.1 | Medical condition in easily understood language |
Overweight and obese individuals at high risk of progression of chronic kidney damage. |
Pacientes con sobrepeso/obesidad con alto riesgo de progresion de daño renal |
|
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 |
|
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 | 10001580 |
E.1.2 | Term | Albuminuria |
E.1.2 | System Organ Class | 10038359 - Renal and urinary 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 |
Assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria. |
Evaluar los efectos reductores de albuminuria utilizando semaglutida 2.4mg s.c. semanalmente (Semaglutida 3mg/ml) comparado con placebo en pacientes no diabeticos con obesidad/sobrepeso y elevada albuminuria |
|
E.2.2 | Secondary objectives of the trial |
Assess the effect of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) on: - eGFR (all patients) - Iohexol measured GFR (46 patients), - change in UACR and eGFR during wash-out from week 24 to 28 - body weight and hip circumference - systolic/diastolic blood pressure - extracellular fluid using bio-impedance spectroscopy (Impedimed FP7) - high sensitivity CRP. |
Evaluar los efectos de la semaglutida 2.4mg s.c. semanalmente (Semaglutida 3mg/ml) es: - eGFR(todos los pacientes) - medida de GFR con Iohexol(46 pacientes) - Cambio en UACR y eGFR durante el periodo de lavado entre la semana 24 y la 28. - Peso corporal y longitud de cadera - Presión arterial Sistoloca/Diastolica - Fluido extracelular usando un espectroscopio de bio-impedancia - PCR de alta sensibilidad |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
GFR substudy: In 46 patients, GFR measurements by plasma clearance of non-radioactive iohexol will be performed at the start and end of the treatment period and after 4 weeks of wash-out from the study drug. Liver stiffness measurement: In a subgroup of patients liver stiffness and liver fat will be measured at baseline and week 24 using a non-invasive device, the fibroscan. |
GFR subestudio: En 46 pacientes, se realizarán mediciones del aclaramiento en plasma de iehoxol no radiactivo, que se realizara al principio y al final del tratamoento y 4 semanas después del periodo de lavado del medicamento de estudio. Medición de la rigidez del hígado: En un subgrupo de pacientes la rigidez hepática y la grasa hepática se medirán al inicio y en la semana 24 utilizando un dispositivo no invasivo, el fibroscan. |
|
E.3 | Principal inclusion criteria |
• Age ≥ 18 years • Body Mass index ≥ 27 kg/m2 • Albuminuria ≥ 30 mg/g and ≤ 3500 mg/g • eGFR ≥ 25 ml/min/1.73m2 • Stable renal function prior to entry into the study defined as no more than 30% eGFR change in 3 months prior to enrolment • Signed Informed Consent |
- Edad ≥ 18 años - Índice de masa corporal ≥ 27 kg/m2 - Albuminuria ≥ 30 mg/g y ≤ 3500 mg/g - eGFR ≥ 25 ml/min/1.73m2 - Función renal estable previa a entrar en el estudio definida como un cambio menor del 30% en eGFR durante los 3 meses previos al screening - Firma del consentimiento informado |
|
E.4 | Principal exclusion criteria |
• Diagnosis with type 1 or type 2 Diabetes • Hba1c ≥ 6.5% at screening • Cardiovascular disease event in 3 months prior to enrollment • Treatment with GLP-1 RA < 4 weeks prior to screening • Uncontrolled thyroid disease TSH>6.0 mIU/L or <0.4 mIU/L at screening • Acute pancreatitis < 180 days prior to screening • History or presence of chronic pancreatitis • Females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures |
- Diagnositco de diabetes tipo 1 o tipo 2 - Hba1c ≥ 6.5% en el screening - Evento de enfermedad cardiovascular en los 3 meses previos al screening - Tratamiento con GLP-1 RA en las 4 semanas previas al screening - Enfermedad de tiroides descontrolada: TSH>6.0 mIU/L o <0.4 mIU/L en el screening - Pancreatitis aguda dentro de los 180 dias previos al screening -Historia o presencia de pancreatitis crónica - Mujeres con posibilidad de quedarse embarazadas que esten embarazadas, dando de mamar o que tengan intención de quedarse embaradas o no usando los métodos anticonceptivos adecuados |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR). |
Cambio del ratio albuina:creatinina en orina (UACR) desde la visita baseline a la semana 24 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Change from baseline to week 24, ie from just before start of treatment untill the end of the treatment period. |
Cambios desde la visita baseline a la semana 24, desde el principio del tratamiento hasta el final del periodo de tratamiento. |
|
E.5.2 | Secondary end point(s) |
Changes from baseline to week 24 in the following parameters: - eGFR (all subjects) - Iohexol measured GFR (46 subjects) - Change in UACR and eGFR during wash-out from week 24 to 28 - Body weight and hip circumference - Systolic/diastolic blood pressure - Extracellular fluid using bio-impedance spectroscopy (Impedimed FP7) - High sensitivity CRP |
Evaluar los efectos de la semaglutida 2.4mg s.c. semanalmente (Semaglutida 3mg/ml) es: - eGFR(todos los pacientes) - medida de GFR con Iohexol(46 pacientes) - Cambio en UACR y eGFR durante el periodo de lavado entre la semana 24 y la 28. - Peso corporal y longitud de cadera - Presión arterial Sistoloca/Diastolica - Fluido extracelular usando un espectroscopio de bio-impedancia - PCR de alta sensibilidad |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Change from baseline to week 24, ie from just before start of treatment untill the end of the treatment period. |
Cambios desde la visita baseline a la semana 24, desde el principio del tratamiento hasta el final del periodo de tratamiento. |
|
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 | Yes |
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 | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 |
|
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 |
ültima visita del último paciente |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |