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    Summary
    EudraCT Number:2020-005187-63
    Sponsor's Protocol Code Number:FM101-CTP2-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-02-11
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-005187-63
    A.3Full title of the trial
    A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the safety, absorption and elimination of FM101, a new compound in the treatment of non-alcoholic fatty liver disease.
    A.3.2Name or abbreviated title of the trial where available
    Phase II Nonalcoholic Steatohepatitis (NASH) study
    A.4.1Sponsor's protocol code numberFM101-CTP2-001
    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 SponsorFuture Medicine Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    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 supportFuture Medicine Co., Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFuture Medicine Co, Ltd.
    B.5.2Functional name of contact pointMedical Expert
    B.5.3 Address:
    B.5.3.1Street AddressRm. 616, LH-Business Growth Center, 54 - Changeop-ro, Sujeong-gu, Seongnam-si
    B.5.3.2Town/ cityGyeonggi-do
    B.5.3.3Post code13449
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+8222289 8690
    B.5.5Fax number+822525 2738
    B.5.6E-mailhsa387@futuremedicine.co.kr
    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 nameNot Applicable
    D.3.2Product code FM101
    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 INNNot Assigned
    D.3.9.2Current sponsor codeFM101
    D.3.9.3Other descriptive name20191002CM001 - FM101/STG-03
    D.3.9.4EV Substance CodeSUB213807
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboTablet
    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
    Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)
    E.1.1.1Medical condition in easily understood language
    Chronic liver disease
    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 LLT
    E.1.2Classification code 10029530
    E.1.2Term Non-alcoholic fatty liver
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    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
    To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH)

    To assess the treatment effect of FM101 on serum alanine aminotransferase (ALT) concentrations after 13 weeks of treatment
    E.2.2Secondary objectives of the trial
    To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging- (MRI)-magnetic resonance elastography (MRE) in patients with NAFLD or NASH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be able and willing to provide written informed consent to take part in the study and to comply with all the study’s requirements.
    2. Be a man or woman ≥18 years of age at screening.
    3. Have
    a. Histologic confirmation of NASH no more than 12 months before the screening visit date, demonstrating the existence of steatosis ≥5%, hepatocyte ballooning and chronic inflammation (at least 1 point for each component), and stage 1 through stage 3 liver fibrosis according to the NASH Clinical Research Network (CRN); OR
    b. NAFLD based upon demonstration of at least 3 of the following 5 components of the metabolic syndrome below, at screening:
    • FPG ≥100 mg/dL (≥5.6 mmol/L), or undergoing drug treatment for elevated plasma glucose concentrations
    • HDL-C concentration <40 mg/dL in male patients, or <50 mg/dL in female patients, or undergoing drug treatment for reduced serum HDL-C concentrations
    • Serum triglyceride (TG) concentration ≥150 mg/dL, or undergoing drug treatment for elevated serum TG concentrations
    • Waist circumference >102 cm in male patients or >88 cm in female patients
    • Systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥85 mm Hg, or undergoing drug treatment for hypertension, or antihypertensive drug treatment in a patient with a history of systemic hypertension
    4. Serum ALT concentration >1 × ULN at screening
    5. FIB-4 result >1.3 and ≤3.25, at screening:
    • If the FIB-4 result is ≥1.3 but ≤1.45, OR >2.67 and ≤3.25, the patient must undergo Fibroscan (VCTE) before proceeding to MRI studies.
    • The Fibroscan (VCTE) result must be >4 kPa but ≤12.5 kPa.
    • If such a Fibroscan (VCTE) result exists from the 3-month period before screening visit date, this result may be used.
    6. Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period.
    7. Undergo MRI-MRE with a score ≥2.9 kPa during the screening period.
    8. WOCBP must have a negative serum β-human chorionic gonadotropin test result at screening.
    Female patients must agree to use at least 1 highly effective birth control throughout the study and up to 30 days after the last dose of study drug has been taken. Highly effective contraception measures include the following options, but are not limited to:
    • Combined estrogen- and progestogen-containing hormonal contraception (administration may be oral, intravaginal, or transdermal);
    • Progestogen-only hormonal contraception associated with inhibition of ovulation (administration may be oral, injectable, or implantable);
    • Intrauterine device, intrauterine hormone-releasing system, bilateral tubal, occlusion (‘tubal occlusion’ includes ‘tubal ligation’);
    • Vasectomized partner (provided that the male has provided confirmation of surgical success and in the event that the vasectomized partner is the sole sexual partner of the woman of childbearing potential);
    • Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk in relation to the duration of the clinical trial), only in the event that this is the preferred lifestyle of the patient.
    Childbearing potential is defined as being fertile after menarche and until becoming postmenopausal unless permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
    A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause.
    Men with partners who are WOCBP must either be surgically sterile or agree to use a barrier contraceptive for the duration of the study and up to 30 days after the last dose of study drug.
    9. Be willing to maintain a stable diet, including alcohol intake where this applies, and physical activity levels throughout the entire study.
    E.4Principal exclusion criteria
    1. Any patient who refuses to provide written informed consent to take part in the study, and/or appears unwilling to comply with study-specific requirements
    2. Female persons who are pregnant or are breastfeeding at screening, or who plan to become pregnant during the study
    3. BMI <25 kg/m2
    4. Any of the laboratory test abnormalities at screening (see the list in the protocol section 8.2 Exclusion Criteria)
    5. Chronic liver disease other than confirmed NASH or NAFLD, including but not limited to the diagnoses/entities (see the list in the protocol section 8.2 Exclusion Criteria)
    6. Medical, histologic, and/or imaging history of hepatic cirrhosis
    7. Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, nonbleeding gastro-oesophageal varices
    8. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness
    9. Chronic use (≥12 months) of any drug known to be associated with development of NAFLD during the 5 years before the anticipated Day 1 visit date (eg, amiodarone, methotrexate, systemic glucocorticoids [unless employed at physiologic replacement doses for management of confirmed adrenal insufficiency], tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement therapy, anabolic steroids [other than testosterone replacement preparations being taken at a physiologic replacement dose for management of confirmed male hypogonadism], sodium valproate, and other hepatotoxins such as minocycline)
    10. Use of the medications (see the list in the protocol section 8.2 Exclusion Criteria)
    11. History of significant alcohol consumption, defined as an average of >20 g/day in female patients and >30 g/day in male patients, for a period of >3 consecutive months within 1 year before screening, hazardous alcohol use (Alcohol Use Disorders Identification Test score ≥8), or an inability to reliably quantify alcohol consumption based upon judgment of the investigator
    12. Use of legally prohibited substance or substances within 1 year before the screening visit date in a manner that may jeopardize the patient’s willingness and/or ability to complete study requirements, in the judgment of the investigator.
    13. Weight change ≥7% within the 6 months before screening or ≥5% within the 3 months before screening
    14. Prior or planned (during the study period) weight reduction surgery (eg, sleeve gastrectomy, Roux-en-Y gastrojejunostomy)
    15. Type 1 diabetes mellitus by medical history
    16. Poorly controlled type 2 diabetes mellitus (this is defined as HbA1c >9.5% at screening, or a patient whose oral antidiabetic medication dosing requires adjustment >10% less than 2 months before the screening visit date).
    17. Uncontrolled systemic hypertension (either treated or untreated) defined as systolic blood pressure >160 mm Hg or a diastolic blood pressure >100 mm Hg at screening. A retest of blood pressure, (after establishing good blood pressure control within a reasonable period of time and up to the Baseline visit) is permissible at the discretion of the investigator
    18. Patients who demonstrate recent evidence (within 6 months of the anticipated date of the Day 1 visit) of clinically evident and significant atheromatous cardiovascular disease (eg, unstable angina, acute coronary syndrome, myocardial infarction, cerebrovascular accident [stroke], cerebrovascular ischemia, transient ischemic attack, and / or peripheral vascular disease requiring intervention)
    19. Has taken part in a clinical trial and been administered an active investigational product being evaluated for the treatment of NASH, weight reduction and / or type 2 diabetes mellitus, during the 6 months before the anticipated Day 1 visit date
    20. Has participated in an investigational new drug trial during the 30 days before screening visit date, or within 5 half-lives of an investigational agent, whichever is longer
    21. Has a confirmed diagnosis of malignancy within 5 years before screening, except for basal or squamous cell carcinoma of the skin that has been treated successfully or cervical carcinoma in situ that has been treated successfully. Patients with a history of other malignancies that have been treated with curative intent and who have no demonstrable disease recurrence within 5 years before screening may also be eligible if approved after discussion with the sponsor’s medical monitor. Patients under evaluation for malignant disease currently are not eligible for study participation.
    22. Patients who are unable to undergo MRI studies, whatever the reason for this
    23. Any other condition that, in the opinion of the investigator, would impede compliance with, hinder completion of the study, compromise the well-being of the patient, and / or interfere with the study’s endpoints.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number and percentage of patients with TEAEs, related TEAEs, and/or severe TEAEs [Time Frame: From administration of FM101 on Day 1 to the last follow up visit]
    2. Change from Baseline to postbaseline assessments during 13 weeks of treatment in serum ALT concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Time Frame: From administration of FM101 on Day 1 to the last follow up visit
    2. during 13 weeks
    E.5.2Secondary end point(s)
    Changes from Baseline to Week 13 in liver stiffness (kPa) on MRE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 13
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 trial3
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months26
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months26
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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