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    Summary
    EudraCT Number:2019-003048-63
    Sponsor's Protocol Code Number:MK-3655-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003048-63
    A.3Full title of the trial
    A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
    Studio di Fase 2b Randomizzato, in Doppio Cieco, Controllato con Placebo per Valutare l’Efficacia e la Sicurezza di MK-3655 in Soggetti Affetti da Steatoepatite Non Alcolica in Fase di Pre-cirrosi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2b Study of MK-3655 in Individuals with Pre cirrhotic Nonalcoholic Steatohepatitis (NASH)
    Studio di Fase 2b con MK-3655 in Soggetti Affetti da Steatoepatite Non Alcolica in Fase di Pre-cirrosi
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberMK-3655-001
    A.5.4Other Identifiers
    Name:INDNumber:134888
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia Srl
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number0039090636191371
    B.5.5Fax number00390636380371
    B.5.6E-mailgcto.italy@merck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMK-3655
    D.3.2Product code [MK-3655]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMK-3655
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMK-3655
    D.3.2Product code [MK-3655]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMK-3655
    D.3.9.2Current sponsor codeMK-3655
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nonalcoholic Steatohepatitis (NASH)
    Steatoepatite Non Alcolica (NASH)
    E.1.1.1Medical condition in easily understood language
    Nonalcoholic Steatohepatitis (NASH)
    Steatoepatite Non Alcolica (NASH)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the effect of each dose of MK-3655 versus placebo on the proportion of individuals with nonalcoholic steatohepatitis (NASH) resolution without worsening of fibrosis after 52 weeks.
    2. To evaluate the safety and tolerability of MK-3655 compared with placebo.
    1. Valutare l'effetto di ciascuna dose di MK-3655 rispetto al placebo sulla percentuale di soggetti con risoluzione della steatoepatite non alcolica (NASH) senza peggioramento della fibrosi dopo 52 settimane.
    2. Valutare la sicurezza e la tollerabilità di MK-3655 rispetto al placebo.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of each dose of MK-3655 versus placebo on mean percent relative reduction from baseline in liver fat content (LFC) after 24 weeks.
    2. To evaluate the effect of each dose of MK-3655 versus placebo on the proportion of individuals with >=1 stage improvement in fibrosis without worsening of steatohepatitis after 52 weeks.
    3. To evaluate the effect of each dose of MK-3655 versus placebo on the proportion of individuals with >=2 point improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) without worsening of fibrosis after 52 weeks.
    1. Valutare l'effetto di ciascuna dose di MK-3655 rispetto al placebo sulla riduzione della percentuale media relativa rispetto al basale del contenuto di grasso epatico (LFC) dopo 24 settimane.
    2. Valutare l'effetto di ciascuna dose di MK-3655 rispetto al placebo sulla proporzione di soggetti con miglioramento >=1 dello stadio della fibrosi senza peggioramento della steatoepatite dopo 52 settimane.
    3. Valutare l'effetto di ciascuna dose di MK-3655 rispetto al placebo sulla proporzione di soggetti con un miglioramento >=2 punti nel punteggio di attività della malattia di fegato grasso non alcolico (NAS) senza peggioramento della fibrosi dopo 52 settimane.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has histological confirmation of NASH based upon a liver biopsy obtained <=6 months before Visit 1/Screening. If no acceptable biopsy performed <=6 months before Visit 1/Screening is available, a liver biopsy will be performed at Visit 3/Liver Biopsy.
    Histological criteria for study entry include:
    - NAS >=4 with a score >=1 point in each component (steatosis, ballooning, and lobular inflammation),
    AND
    - NASH CRN fibrosis score of Stage 2 or 3.
    2. Has an MRI-PDFF >=8% as assessed at Visit 2/MRI-PDFF.
    3. Has a baseline MELD-Na score <=12 at Visit 1/Screening.
    4. Is a male or a postmenopausal female aged 18 years to 80 years (in Japan, aged 20 to 80 years), at the time of signing the ICF.
    5. Has a BMI >=25 kg/m2 and <=50 kg/m2 at the time of Visit 1/Screening.
    6. Has stable weight (based on self-reporting) defined as <=5% gain or loss of body weight for at least 3 months before Visit 1/Screening.
    7. Meets one of the following criteria:
    - Has no history of T2DM.
    OR
    - Has a history of T2DM with an A1C <=9.0% at Visit 1/Screening and controlled by diet or stable doses of AHAs.
    8. Has a systolic blood pressure of <=160 mm Hg and a diastolic blood pressure <=90 mm Hg (after at least a 10-minute seated rest) based on the mean of 3 measurements at Visit 5/Randomization.
    9. Be willing and able to comply with scheduled visits, treatment plan, laboratory tests,and/or other study procedures.
    10. Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    11. Is a postmenopausal female.
    12. The participant (or legally acceptable representative, if applicable) provides written informed consent for the study. The participant may also provide consent for FBR. However, the participant may participate in the main study without participating in FBR.
    1. Presenta conferma istologica di NASH basata su una biopsia epatica eseguita <=6 mesi prima della Visita 1/Screening. Se non è disponibile una biopsia epatica accettabile eseguita <=6 mesi prima della Visita 1/Screening, verrà eseguita una biopsia epatica in occasione della Visita 3/Biopsia Epatica. I criteri istologici di inclusione nello studio sono i seguenti:
    • NAS >=4 con punteggio >=1 per ciascun componente (steatosi, ballooning e infiammazione lobulare)
    E
    • fibrosi di Stadio 2 o 3 sulla base del sistema di punteggio NASH CRN.
    2. Presenta un valore di MRI-PDFF >=8% come da valutazione alla Visita 2/MRI-PDFF.
    3. Presenta un punteggio MELD-Na al basale <=12 alla Visita 1/Screening.
    4. È un uomo o una donna in postmenopausa tra i 18 e gli 80 anni di età (in Giappone tra i 20 e gli 80 anni) all’atto della firma del modulo di consenso informato.
    5. Ha un BMI >=25 kg/m2 e <=50 kg/m2 al momento della Visita 1/Screening.
    6. Ha peso stabile (sulla base di un’autovalutazione), definito come aumento o perdita di peso <=5% per almeno 3 mesi prima della Visita 1/Screening.
    7. Soddisfa almeno uno dei seguenti criteri:
    • Non ha un’anamnesi di DMT2
    O
    • Ha un’anamnesi di DMT2 con A1C <=9,0% alla Visita 1/Screening, controllato con dieta o con dosi stabili di AHA (farmaci anti-iperglicemizzanti).
    8. Ha una pressione arteriosa sistolica <=160 mm Hg e una pressione arteriosa diastolica <=90 mm Hg (dopo almeno 10 minuti di riposo in posizione seduta) basate sulla media di 3 misurazioni alla Visita 5/Randomizzazione.
    9. Essere disponibile e in grado di sottoporsi alle visite programmate, al piano terapeutico, agli esami di laboratorio e/o ad altre procedure dello studio.
    10. L’uso dei contraccettivi da parte dei pazienti di sesso maschile deve essere coerente con i regolamenti locali riguardanti i metodi contraccettivi per chi partecipa a studi clinici.
    11. Essere una donna in postmenopausa.
    12. Il partecipante (o il rappresentante legalmente riconosciuto, ove applicabile) fornisce il consenso informato scritto per lo studio. Il partecipante può inoltre fornire il consenso a partecipare a future ricerche biomediche. Tuttavia, il soggetto può partecipare allo studio principale senza partecipare a future ricerche biomediche.
    E.4Principal exclusion criteria
    1. Has presence of cirrhosis on liver biopsy.
    2. Has Type 1 diabetes.
    3. Has a history of malignancy, unless cancer free >=5 years, or is under evaluation for active or suspected malignancy before signing the ICF except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
    4. Has a history of bariatric surgery <=5 years before Visit 1/Screening.
    5. Has undergone a major surgical procedure <=3 months before signing the ICF or has major surgery planned during the study.
    6. Has a history or evidence of:
    -Chronic liver disease other than NASH
    -Hepatitis B as defined by the presence of HBsAg
    -Hepatitis C as defined by the presence of HCV RNA or positive hepatitis C antibody (anti-HCV); participants with a history of HCV infection may be included if HCV PCR is negative >=3 years
    -Drug-induced liver disease
    -Ongoing autoimmune liver disease
    -Decompensated liver disease
    -HIV
    -Primary biliary cirrhosis
    -Primary sclerosing cholangitis
    -Reye Syndrome
    -Splenomegaly
    -Wilson’s disease
    -Documented Cushing disease, Cushing syndrome, or any condition associated with hypercortisolism
    -Hypothyroidism, hyperthyroidism, or subclinical thyroid disease
    -Alpha-1-antitrypsin deficiency
    -Hemochromatosis or iron overload
    -Spontaneous bacterial peritonitis
    -Known bile duct obstruction
    -Hepatocellular carcinoma
    -Untreated obstructive sleep apnea
    -Hemostasis disorder
    -Hematological disorder
    7. Has significant systemic or major illnesses other than liver disease, including recent events (<=6 months before Visit 1/Screening) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation.
    8. Has a known hypersensitivity to any of the ingredients or excipients of the IMP.
    9. Has experienced any bone trauma, fracture, or bone surgery <=2 months before Visit 1/Screening.
    10. Has a history of osteoporosis or an indication that requires treatment with a bone-active pharmacological agent in the classes listed in exclusion criterion #18 at Visit 1/Screening.
    11. Has current or history of significant alcohol consumption for a period of more than 3 consecutive months <=24 months before Visit 1/Screening.
    12. Has an inability to reliably quantify alcohol consumption.
    13. Has a recent history of drug abuse (defined as <=3 years) or is a current user of recreational or illicit drugs at the time of Visit 1/Screening.
    14. Has a known psychiatric or any other cognitive disorder per the opinion of the investigator, that would interfere with the participant’s ability to cooperate with the requirements of the study.
    15. Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator.
    16. Has a total score >12 on the PHQ-9.
    17. Is on treatment with or has used the following agents <=24 months before Visit 1/Screening:
    -Thiazolidinediones
    -Fibric acid derivatives
    -Obeticholic acid
    -High dose vitamin E (>400 IU/day)
    -L-ornithine L-aspartate

    For remaining criteria refer to protocol
    1. Denota presenza di cirrosi alla biopsia epatica.
    2. Ha il diabete di tipo 1.
    3. Presenta un’anamnesi di neoplasia maligna, a meno che non sia privo di affezioni tumorali da >=5 anni, o è in fase di valutazione per una neoplasia maligna attiva o sospetta prima di sottoscrivere il modulo di CI, a eccezione di un tumore cutaneo adeguatamente trattato o di un carcinoma in situ della cervice uterina.
    4. Presenta un’anamnesi di chirurgia bariatrica risalente a <=5 anni prima della Visita 1/Screening.
    5. Si è sottoposto a una procedura chirurgica importante <=3 mesi prima di sottoscrivere il modulo di CI o ha in programma un intervento chirurgico importante da svolgersi nel corso dello studio.
    6. Ha un’anamnesi o evidenza di:
    -Malattia epatica cronica diversa dalla NASH
    -Epatite B definita dalla presenza di HBsAg
    -Epatite C definita dalla presenza di HCV nell’RNA o dalla positività per l’anticorpo diretto contro il virus dell’epatite C (anti-HCV); i partecipanti con un’anamnesi di infezione da HCV possono essere inclusi se il test di reazione a catena della polimerasi (PCR) per l’HCV è negativo da >=3 anni
    -Malattia epatica farmaco-indotta
    -Malattia epatica autoimmune in corso
    -Epatopatia decompensata
    -HIV
    -Cirrosi biliare primitiva
    -Colangite sclerosante primitiva
    -Sindrome di Reye
    -Splenomegalia
    -Morbo di Wilson
    -Malattia di Cushing, sindrome di Cushing o qualsiasi condizione associata a ipercortisolismo documentate
    -Ipotiroidismo, ipertiroidismo o patologia tiroidea subclinica
    -Carenza di alfa-1-antitripsina
    -Emocromatosi o sovraccarico di ferro
    -Peritonite batterica spontanea
    -Nota ostruzione del dotto biliare
    -Carcinoma epatocellulare
    -Apnea ostruttiva del sonno non trattata
    -Disturbo emostatico
    -Patologia ematologica
    7. Ha malattie sistemiche o gravi significative che non siano patologie a carico del fegato, compresi eventi recenti (<=6 mesi prima della Visita 1/Screening) di insufficienza cardiaca congestizia, coronaropatia instabile, rivascolarizzazione arteriosa, broncopneumopatia, insufficienza renale, ictus, attacco ischemico transitorio o trapianto d’organo.
    8. Ha un’ipersensibilità nota a qualsiasi componente o eccipiente dell’IMP (prodotto per uso clinico).
    9. Ha sperimentato qualsiasi trauma osseo, frattura o intervento di chirurgia ossea <=2 mesi prima della Visita 1/Screening.
    10. Ha un’anamnesi di osteoporosi o un’indicazione al trattamento con un agente farmacologico attivo a livello osseo di una delle classi elencate al criterio di esclusione n. 18 alla Visita 1/screening.
    11. Presenta evidenza attuale o anamnesi di consumo significativo di alcolici per un periodo maggiore di 3 mesi consecutivi <=24 mesi prima della Visita 1/Screening.
    12. È incapace di quantificare in modo affidabile il consumo di alcolici.
    13. Ha una recente anamnesi (negli ultimi 3 anni) di abuso da sostanze stupefacenti o è un consumatore di sostanze stupefacenti illegali o a uso ricreativo al momento della Visita 1/Screening.
    14. Presenta disturbi noti di natura psichiatrica o altri disturbi di natura cognitiva, a giudizio dello sperimentatore, che potrebbero interferire con il rispetto dei requisiti dello studio.
    15. È a rischio imminente di arrecare danno a sé stesso, sulla base del colloquio clinico e delle risposte al questionario C SSRS o di arrecare danno ad altri, secondo il giudizio dello sperimentatore.
    16. Totalizza un punteggio >12 nella compilazione del questionario PHQ-9.
    17. È in terapia con o ha utilizzato i seguenti agenti <=24 mesi prima della Visita 1/Screening:
    -Tiazolidinedioni
    -Derivati degli acidi fibrici
    -Acido obeticolico
    -Vitamina E ad alte dosi (>400 UI/die)
    -L-ornitina L-aspartato

    Per i restanti criteri fare riferimento al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants with NASH resolution without worsening fibrosis assessed with the NASH Clinical Research Network (CRN) scoring system (evaluated by blinded independent central review [BICR]) after 52 weeks
    2. Percentage of participants with adverse events (AEs) up to 56 weeks
    3. Percentage of participants discontinuing study intervention due to adverse events (AEs) up to 52 weeks
    1. Percentuale di soggetti con risoluzione della NASH senza peggioramento della fibrosi, misurata mediante sistema di punteggio NASH CRN (valutata tramite BICR), dopo 52 settimane
    2. Percentuale di soggetti con eventi avversi (EAs) fino a 56 settimane
    3. Percentuale di soggetti cche hanno interrotto il trattamento a causa di eventi avversi (EAs) fino a 52 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At 52 weeks
    2. Up to 56 weeks
    3. Up to 52 weeks
    1. Alla Settimana 52
    2. Fino a 56 settimane
    3. Fino a 52 settimane
    E.5.2Secondary end point(s)
    1. Change from baseline in liver fat content (LFC) (%) measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) (evaluated by BICR) after 24 weeks
    2. Percentage of participants with >=1 stage improvement in fibrosis without worsening of steatohepatitis assessed with the NASH CRN scoring system (evaluated by BICR) after 52 weeks
    3. Percentage of participants with >=2 point improvement (PI) in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) with >=1 PI in inflammation/ballooning without worsening fibrosis by NASH CRN scoring system (evaluated by BICR) after 52 weeks
    1. Variazione dal basale in percentuale del contenuto di grasso epatico (LFC) misurata attraverso MRI-PDFF (valutata tramite BICR) dopo 24 settimane
    2. Percentuale di soggetti con un miglioramento della fibrosi >= 1 stadio senza peggioramento della steatoepatite, misurato mediante sistema di punteggio NASH CRN (valutato tramite BICR) dopo 52 settimane
    3. Percentuale di soggetti con un miglioramento della NAS >= 2 punti con miglioramento dell’infiammazione o del ballooning >=1 punto senza peggioramento della fibrosi, misurato mediante sistema di punteggio NASH CRN (valutato tramite BICR) dopo 52 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and 24 Weeks
    2. At 52 weeks
    3. At 52 weeks
    1. Al Basale e alla Settimana 24
    2. Alla Settimana 52
    3. Alla Settimana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Chile
    China
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Taiwan
    Turkey
    United States
    France
    Germany
    Italy
    Spain
    Argentina
    E.8.7Trial 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 98
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 328
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-13
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