Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44236   clinical trials with a EudraCT protocol, of which   7337   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-005057-87
    Sponsor's Protocol Code Number:337HNAS21016
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-09-15
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-005057-87
    A.3Full title of the trial
    A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with Non-alcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to find out how safe and effective Lanifibranor is in patients
    with Non-alcoholic steatohepatitis (NASH) and type 2 Diabetes.
    Lanifibranor will be studied when taken alone or in combination with
    Empagliflozin.
    A.3.2Name or abbreviated title of the trial where available
    LEGEND
    A.4.1Sponsor's protocol code number337HNAS21016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05232071
    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 SponsorInventiva S.A.
    B.1.3.4CountryFrance
    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 supportInventiva SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInventiva S.A.
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address50 rue de Dijon
    B.5.3.2Town/ cityDaix
    B.5.3.3Post code21121
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447710467284
    B.5.6E-mailSanjaykumar.PATEL@inventivapharma.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 nameLanifibranor
    D.3.2Product code IVA337
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlanifibranor
    D.3.9.1CAS number 927961-18-0
    D.3.9.2Current sponsor codeIVA337
    D.3.9.3Other descriptive name1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
    D.3.9.4EV Substance CodeSUB176833
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 Yes
    D.2.1.1.1Trade name Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameJardiance
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEmpagliflozin
    D.3.9.1CAS number 864070-44-0
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 Diabetes (T2DM) with Non-Alcoholic Steatohepatitis (NASH)
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes (T2DM) with Non-Alcoholic Steatohepatitis (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 24.1
    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
    Primary objective
    To assess the effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on HbA1c after a 24-week treatment duration.

    Secondary objectives
    To assess the effect of lanifibranor alone compared to placebo and lanifibranor in combination with empagliflozin compared to placebo after a 24-week treatment duration on:
    • Liver tests
    • Markers of glycemic control and insulin resistance
    • Inflammatory markers
    • Lipid parameters
    • Body weight and body composition
    and
    To assess the safety and tolerability of lanifibranor alone and in combination with empagliflozin during the 24-week treatment period and the 4-week follow-up period.

    Exploratory objectives
    To assess the effect of lanifibranor alone compared to placebo and lanifibranor in combination with empagliflozin compared to placebo after a 24 week treatment duration on hepatic fat content, steatosis, inflammation and fibrosis...

    E.2.2Secondary objectives of the trial
    Secondary objectives
    To assess the effect of lanifibranor alone compared to placebo and lanifibranor in combination with empagliflozin compared to placebo after a 24-week treatment duration on: Liver tests, Markers of glycemic control and insulin resistance, Inflammatory markers, Lipid parameters , Body weight and body composition and
    To assess the safety and tolerability of lanifibranor alone and in combination with empagliflozin during the 24-week treatment period and the 4-week follow-up period.

    Exploratory objectives :
    To assess the effect of lanifibranor alone compared to placebo and lanifibranor in combination with empagliflozin compared to placebo after a 24-week treatment duration on: Hepatic fat content ; Steatosis, inflammation and fibrosis ; NASH and fibrosis non-invasive biomarkers; Liver elasticity and tissue attenuation; Liver stiffness; The time to initiation of a rescue medication.
    To perform population pharmacokinetic (popPK) modelling of lanifibranor
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For an eligible patient, all inclusion criteria must be answered “yes” at Screening and re-confirmed at the time of randomization procedure and at Baseline (i.e., before treatment initiation). Laboratory tests taken during the screening period will be used to determine eligibility. If information cannot be confirmed in the medical record, responses will be obtained in a patient interview:
    1. Able to understand the nature of the study, willing and able to comply with the study procedures and restrictions, and willing to provide informed consent obtained before any study-related activities
    2. The patient is willing to continue on the study in case of moving or relocating to a different region/city where there would be no active study site
    3. Able to communicate meaningfully with the Investigator and legally competent to provide written informed consent
    4. Male or female, aged ≥ 18 years at the time of signing informed consent
    5. Diagnosis of NASH
    a. based on a historical (within 12 months prior to Screening) liver biopsy with a non-alcoholic fatty liver disease activity score (NAS) ≥ 4 with a score of one or more in each sub-component (steatosis, hepatocyte ballooning, lobular inflammation) and no documented cirrhosis in the last 12 months prior to Screening OR
    b. NASH at Screening
    b1. High Risk NASH defined as cT1 ≥ 875 ms assessed by LiverMultiScan® OR
    b2. NASH defined as cT1 ≥ 825 ms assessed by LiverMultiScan® and hepatic fat content ≥ 10% assessed by MRI-PDFF
    6. HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin (≥ 1,000 mg/day), and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Doses have no qualitative change for 3 months prior to informed consent. These medicines will be continued at stable doses during the entire study.
    7. Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal. Women of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) have to use a highly effective method of contraception throughout the study and for one month after treatment discontinuation. Highly effective contraceptive methods are defined as follows: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (provided he is her sole sexual partner and he has received medical assessment of the surgical success), and true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient) whereas periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    E.4Principal exclusion criteria
    A. Liver-related:
    1. Documented causes of chronic liver disease other than NASH (see protocol for details, see exclusion criteria no 50 for autoimmune hepatitis)
    2. Histologically documented liver cirrhosis (fibrosis F4); or diagnosis ofcirrhosis at Screening
    3. History or current diagnosis of hepatocellular carcinoma (HCC)
    4. History of or planned liver transplant
    5. Documented history of HIV infection
    6. ALT or AST > 5 × upper limit of normal (ULN) at Screening
    7. Abnormal liver function as any :
    a. Albumin < lower limit of normal range (LLN)
    b. INR ≥ 1.3 (unless patient is on anticoagulants)
    c. Total bilirubin level ≥ 1.5 mg/dL (25.7 μmol/L). Patients with Gilbert's syndrome can be enrolled if direct bilirubin is ≤ 0.45 mg/dL (7.7 μmol/L)
    8. Hemoglobin < 110 g/L (11 g/dL) for females and < 120 g/L (12 g/dL) for males
    9. White blood cell count < LLN or a lower count in patients with benignethnic neutropenia, if considered to be clinical insignificant by the investigator
    10. Platelet count < 140,000/μL
    11. Alkaline phosphatase (ALP) > 2 × ULN
    12. Patient currently receiving any approved treatment for NASH or obesity
    13. Current or recent history (< 5 years) of significant alcohol consumption. No binge drinking during the last year.
    14. Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening
    B. Diabetes related (see protocol/synopsis for details)

    C. Obesity related (see protocol/synopsis for details)
    20. BMI > 45 kg/m2 at Screening
    21. Weight change > 5% in 3 months prior to Screening
    22. Introduction of anti-obesity drug or restrictive bariatric surgery in past 12 months prior to Screening or planned bariatric surgery throughWeek 24
    23. Participation in an organized weight loss program in past 6 months prior to Screening or planned participation through Week 24

    D. Cardiovascular related (see protocol/synopsis for details)

    E. General safety:
    30. Significant systemic or major illnesses other than liver disease that would preclude treatment with lanifibranor and/or empagliflozin
    31. Any condition which might jeopardize a patient’s safety or compliance with the protocol, or warrants exclusion from the study
    32. Cancer: Presenceor history of malignancy within 5 years prior to Screening and/or active neoplasm at Screening.
    33. History of bladder disease and/or persistent hematuria within 6 months prior to Screening or current hematuria unless due to a urinary tract infection
    34. Renal impairment measured as eGFR < 60 mL/min as determined by MDRD
    35. Total creatine kinase > 1.5 x ULN
    36. History of pancreatitis, or confirmed pancreatic lipase > 1.3 x ULN, or > 2.0 x ULN upon repeated test within 3 weeks if on a DPP-IVi
    37. Concomitant treatment with PPAR-⍺ agonists (fibrates);
    38. Patients on Vitamin E at doses ≥ 400 IU/day; unless no qualitative change in dose
    39. SARS-CoV-2 infections requiring hospitalization in the last 3 months or current SARS-CoV-2 infection confirmed by a validated test.
    40. Major surgery scheduled during the study
    41. Hypersensitivity to any of the ingredients of the IMPs
    42. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
    43. Previous exposure to lanifibranor or empagliflozin
    44. Osteopenia, or any otherbone disease.
    45. Claustrophobia that prevents tolerance of MRI scanning procedure.
    46. Metallic implant that prevents MRI examination or any other contraindication to MRI
    47. Pregnancy/lactation or inability to adhere to adequate contraception
    48. Treatment with strong inducers or inhibitors of CYP2C8. Prior administration of other drugs as per Section 13.2.
    49. Participation in clinical trial of IMP/device within 3 months from Screening or 5 half-lives of the IMP from Screening,

    F. Autoimmune related:
    50. Predisposition to autoimmune liver disease, incl.
    a. Signs on previous liver biopsy suggestive of autoimmune liver disease (autoimmune hepatitis, immune cholangitis or overlap syndrome)
    b. Family history of autoimmune liver disease in a first degree relative
    c. Autoimmune thyroid disease:
    i. Known diagnosis of autoimmune thyroid disease
    ii. Thyroid replacement hormone unless documented for reason of primary thyroid insufficiency (e.g. due to thyroidectomy, radiation therapy, etc.)
    iii. Positive autoimmune antibodies associated with abnormal thyroid function testing (TSH, T4 or free T3) (1) Anti-thyroid peroxidase antibody (TPO)
    iv. Anti-TSH receptor antibodies (TRAb)
    d. History of or positive testing at screening for: i. Anti-nuclear antibodies (ANA) at a dilution of 1:320 or greater
    一 ii. Anti-mitochondrial antibodies (AMA)
    一 iii. Anti-smooth muscle antibodies (ASMA) at a dilution of 1:320 or greater
    一 iv. Anti-liver kidney microsomal type 1 antibodies (LKM1)
    一 v. Anti-liver cytosol type 1 antibody (LC1)


    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    • Absolute change in HbA1c from baseline (Week 0) to Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline (Week 0) to Week 24
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    The following endpoints will be evaluated at Week 24:
    • Change from baseline to Week 24 in liver tests (alanine aminotransferase [ALT], AST, gamma-glutamyl transferase (GGT), alkaline phosphatase [ALP], total and direct bilirubin)
    • Change from baseline to Week 24 in markers of glycemic control and insulin resistance (determination of hepatic insulin sensitivity, Homeostatic Model Assessment for insulin resistance [HOMA-IR], fasting insulin, fasting plasma glucose [FPG], fructosamine, adiponectin)
    • Binary endpoint defined as reaching HbA1c < 7.0% at Week 24, and no new antidiabetic treatment or increase in dosages of antidiabetic treatments
    • Binary endpoint defined as reaching HbA1c decrease ≥ 0.5% at Week 24, and no new antidiabetic treatment or increase in dosages of antidiabetic treatments
    • Change from baseline to Week 24 in inflammatory markers (high-sensitivity C-reactive protein [hsCRP], Interleukin IL-6, Interleukin IL-1β)
    • Change from baseline to Week 24 in lipid parameters (total cholesterol, low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides [TG])
    • Change from baseline to Week 24 in body weight
    • Binary endpoint defined as reaching body weight increase ≥ 5% at Week 24
    • Change from baseline to Week 24 in body composition as determined by MRI (including but not limited to visceral adipose tissue [VAT], subcutaneous adipose tissue [SAT] and thigh SAT)

    Safety endpoints
    • Adverse events (AEs)
    • Adverse Events of Special Interest (AESIs): anemia, heart failure, aminotransferase elevation, bone fracture, peripheral edema, cholelithiasis, hypoglycemia and ovulation resumption
    • Serious adverse events (SAEs) including major adverse cardiovascular events (MACE) (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, hospitalization for acute coronary syndrome)
    • Physical examination
    • Vital signs (systolic and diastolic blood pressure [SBP, DBP], waist circumference)
    • Electrocardiogram (ECG)
    • Safety laboratory evaluations including N-terminal prohormone B-type natriuretic peptide (NT-pro-BNP)

    Exploratory endpoints
    • Absolute change from baseline to Week 24 in liver fat content (MRI-PDFF)
    • Binary endpoint where a responder is defined reaching a relative decrease in MRI-PDFF of ≥ 30% at Week 24
    • Binary endpoint where a responder is defined as reaching an absolute decrease in MRI-PDFF of ≥ 5% at Week 24
    • Binary endpoint where a responder is defined as reaching ≤ 5.0% MRI-PDFF at Week 24 (i.e., non-alcoholic fatty liver disease (NAFLD) resolution)
    • Changes from baseline to Week 24 in corrected T1 relaxation time (cT1) assessed by LiverMultiScan®
    • Binary endpoint defined as reaching cT1 decrease > 80 ms at Week 24
    • Binary endpoints defined as reaching cT1 < 800 ms at Week 24, and reaching cT1 < 875 ms at Week 24 (among patients with baseline cT1≥875 ms)
    • Changes from baseline to Week 24 in non-invasive biomarkers related to NASH and fibrosis (included but not limited to: TIMP-1, hyaluronic acid, P3NP, cytokeratin CK18M30 and M65, proC3)
    • Changes from baseline to Week 24 in VelacurTM ultrasound measures of liver elasticity (kPa) and attenuation (dB/m) (only applies to sites where VelacurTM is available)
    • Changes from baseline to Week 24 in FibroScan® measures of LSM (kPa), CAP (dB/m) and FAST score (only applies to sites where FibroScan® is available)
    • Time from baseline to initiation of a rescue medication (weeks)

    Pharmacokinetic (PK) endpoints
    • PopPK modelling of trough plasma levels of lanifibranor and its metabolites using a sparse sampling scheme (PK parameters include Cmax, Tmax, AUC, T1/2, CL/F, Vd/F)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline (Week 0) to Week 24 (and intothe 4-week follow-up period specfically for safety and tolerability )
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 Yes
    E.8.1.7.1Other trial design description
    Double-blinded with regards to lanifibranor, open-label with regards to empagliflozin
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    Belgium
    France
    Netherlands
    E.8.7Trial 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
    The Sponsor considers there is no need to have an Data Monitoring Committee (DMC) in this study due to the limited study duration (treatment duration of only 24 weeks), the short period of enrolment (estimated 6 months) and the limited number of subjects to be included (n=63). Rigorous medical monitoring will be conducted by investigators and medical monitors from the CRO/Sponsor and according to the measures detailed hereafter in the study protocol, Section 8.2.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 63
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-06-04
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA