E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Non-alcoholic fatty liver disease with significant fibrosis |
Enfermedad del hígado graso no alcohólico con fibrosis significativa |
|
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 | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029530 |
E.1.2 | Term | Non-alcoholic fatty liver |
E.1.2 | System Organ Class | 100000004871 |
|
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 |
The primary objective of this trial is to evaluate the efficacy of three doses of ZED1227 versus (vs.) placebo for the treatment of patients with NAFLD with fibrosis |
El objetivo principal de este ensayo es evaluar la eficacia de tres dosis de ZED1227 versus (vs.) placebo para el tratamiento de pacientes con NAFLD con fibrosis |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective of this trial is to study the safety of ZED1227 for the treatment of patients with NAFLD with fibrosis |
El objetivo secundario de este ensayo es estudiar la seguridad de ZED1227 para el tratamiento de pacientes con NAFLD con fibrosis |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Has provided signed informed consent - Is a male or female ≥ 18 and < 75 years of age - Has diagnosed NAFLD - Has diagnosed significant fibrosis (stages 2 or 3) |
- Ha proporcionado consentimiento informado firmado - Es hombre o mujer >= 18 y <75 años. - Ha sido diagnosticado NAFLD - Ha sido diagnosticado fibrosis significativa (estadios 2 o 3) |
|
E.4 | Principal exclusion criteria |
- Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males) - Has a history or presence of any other significant concomitant liver diseases - Has diagnosed type 1 diabetes mellitus (T1DM) - Has presence of cirrhosis |
-Tener antecedentes de consumo significativo de alcohol (un promedio de > 20 g/día en mujeres y > 30 g/día en hombres) - Tener antecedentes o presencia de cualquier otra enfermedad significativa concomitante del hígado - Haber sido diagnosticado de diabetes mellitus tipo 1 (T1DM) - Tener presencia de cirrosis |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the relative change of serum levels of PRO C3 |
La variable principal de eficacia será la variación relativa de la concentración sérica de PRO C3 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Between baseline and the EOT/withdrawal visit |
Entre las visitas basal y de FDT/retirada |
|
E.5.2 | Secondary end point(s) |
The secondary efficacy variables include: •Change in the levels of the following non-invasive markers of fibrosis from baseline to selected interim visits and from baseline to the EOT/withdrawal visit: -Enhanced Liver Fibrosis [ELF] Score -Fibrosis-4 [FIB-4] Score -NAFLD Fibrosis Score [NFS] -AST to Platelet Ratio Index [APRI] -ADAPT Score -FIBC3 Score • Absolute and relative (%) change in the levels of the following liver parameters from baseline to each visit up to the EOT/withdrawal visit: -ALT -AST -γ-glutamyltransferase (GGT). |
Las variables secundarias de eficacia incluyen: • Cambio en los niveles de los siguientes marcadores no invasivos de fibrosis desde la visita basal hasta las visitas intermedias seleccionadas y desde la visita basal hasta la EOT / visita de retirada: -Puntuación mejorada de fibrosis hepática [ELF] -Puntuación de fibrosis-4 [FIB-4] -Puntuación de fibrosis NAFLD [NFS] -Índice de relación de AST a plaquetas [APRI] -Puntuación ADAPT -Puntuación FIBC3 • Cambio absoluto y relativo (%) en los niveles del hígado en los siguientes parámetros desde el inicio hasta cada visita hasta la EOT / visita de retirada: -ALT -AST -γ-glutamiltransferasa (GGT). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From baseline to each visit up to the EOT/withdrawal visit |
Desde la visita basal hasta cada visita hasta la EOT / visita de retiro |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 |
Patient-reported outcome |
Resultado informado por el paciente |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 4 |
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 | 40 |
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 |
Belgium |
Czechia |
Germany |
Poland |
Spain |
Ukraine |
France |
|
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
|
LPLV |
Ultimo paciente ultima visita |
|
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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |