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FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

Primary Purpose

Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
FM101 150 mg BID
FM101 300 mg BID
Sponsored by
Future Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease focused on measuring Nonalcoholic Fatty Liver Disease, NAFLD, Nonalcoholic Steatohepatitis, NASH, FM101

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals must meet all of the following criteria to be included in the study:

  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 c. 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 d. NAFLD based upon demonstration of at least 3 of the following 5 components of the metabolic syndrome below, at screening:

    • Fasting plasma glucose ≥100 mg/dL , or undergoing drug treatment for elevated plasma glucose concentrations
    • High-density lipoprotein-cholesterol (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 × upper limit of normal (ULN) at screening
  5. Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period.
  6. Undergo MRE with a score ≥2.9 kPa during the screening period.
  7. Women of childbearing potential (WoCBP) must have a negative serum beta human chorionic gonadotropin (HCG) test result at screening.

    Female patients must agree to use 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, but not limited to:

    • Combined estrogen- and progestogen-containing hormonal contraception (oral, intravaginal and transdermal);
    • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable);
    • Intrauterine device, intrauterine hormone-releasing system, bilateral tubal, occlusion ('tubal occlusion' includes 'tubal ligation');
    • Vasectomized partner (only in the event that the vasectomized partner is the sole sexual partner of the WoCBP);
    • Sexual abstinence (defined as refraining from heterosexual intercourse) only in the event that this is the preferred lifestyle of the patient.

    Childbearing potential is defined as being fertile following 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.

  8. Be willing to maintain a stable diet, including alcohol intake this applies, and physical activity throughout the entire study.

Exclusion Criteria:

Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:

  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. Body mass index (BMI) <25 kg/m2.
  4. Fibrosis-4 index (FIB-4) >2.6 at screening.
  5. Any of the following laboratory test abnormalities at screening:

    1. Serum ALT and/or AST concentration >5 × upper limit of normal (ULN)
    2. Total serum bilirubin (BR) concentration >ULN; if an established diagnosis of Gilbert's syndrome exists and the direct serum BR result at screening is less than or equal to ULN the patient may participate in the study
    3. Serum albumin concentration ≤3.5 g/dL
    4. International normalized ratio (INR) ≥1.3
    5. Platelet count less than the lower limit of normal range (LLN)
    6. Creatinine clearance rate <60 mL/minute as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation
    7. Positive COVID-19 polymerase chain reaction (PCR) test result at screening NOTE: Repeat testing of a given parameter or parameters that returned ineligible results, may be performed during the same screening period in consultation with the sponsor's Medical Monitor. An interval of at least 7 days should exist between receipt of the ineligible test result and re-testing.
  6. Chronic liver disease other than confirmed or suspected NASH, including but not limited to the following diagnoses / entities:

    1. Chronic hepatitis B virus infection (defined by the presence of hepatitis B surface antigen at screening) and / or chronic hepatitis C virus (HCV) infection (defined by the presence of detectable HCV ribonucleic acid (RNA) antibody [anti-HCV] at screening). Patients whose anti-HCV antibody test at screening is positive, but who test negative for HCV RNA at screening will be permitted to participate in the study as long as there has been evidence of viral negativity for at least 24 months prior to screening)
    2. Autoimmune hepatitis (AIH), or confirmed overlap syndrome of AIH and either primary biliary cholangitis or primary sclerosing cholangitis.
    3. Primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis whatever the basis for this, e.g. chronic pancreatitis resulting in bile duct stricture formation, recurrent extrahepatic bile duct calculus formation, arterial insult resulting in bile duct stricture formation
    4. Wilson's disease, homozygous alpha-1-anti-trypsin deficiency, hemochromatosis, drug-induced liver disease
    5. Alcoholic liver disease
    6. Suspected or confirmed hepatocellular carcinoma
  7. Medical, histologic, and/or imaging history of hepatic cirrhosis.
  8. Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, non-bleeding gastro-oesophageal varices.
  9. Known history of human immunodeficiency virus (HIV) infection.
  10. Chronic use (≥12 months) of any drug known to be associated with development of NAFLD during the five years before the anticipated Day 1 visit date, e.g. 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, e.g. minocycline.
  11. Use of the following medications:

    1. GLP-1 agonists, unless on a stable dose for at least 3 months prior to screening
    2. Thiazolidinediones, obeticholic acid or vitamin E at a daily dose >400 IU daily within the 6 months before screening
    3. Statin therapy and other lipid-modifying therapies must have been used at a stable dose for ≥3 months prior to screening
    4. Oral antidiabetic medication(s) (other than those specifically excluded) must have been used / taken at a stable daily dose for ≥3 months prior to screening
  12. 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 prior to 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.
  13. Active substance abuse within the 1 year before the screening visit date, upon the judgement of the investigator.
  14. Weight change ≥7% within the 6 months prior to screening or ≥5% within the 3 months prior to screening.
  15. Prior or planned (during the study period) weight reduction surgery, e.g. sleeve gastrectomy, Roux-en-Y gastrojejunostomy.
  16. Type 1 diabetes mellitus by medical history.
  17. Poorly controlled type 2 diabetes mellitus (this is defined as hemoglobin A1c (HbA1c) >9.5% at screening, or a patient whose oral anti-diabetic medication dosing requires adjustment >10% less than 2 months before the screening visit date.
  18. Uncontrolled systemic hypertension (either treated or untreated) defined as systolic blood pressure >160 mmHg or a diastolic blood pressure >100 mmHg 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.
  19. 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, e.g. unstable angina, acute coronary syndrome, myocardial infarction, cerebrovascular accident [stroke], cerebrovascular ischemia, transient ischemic attack, and / or peripheral vascular disease requiring intervention.
  20. 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 prior to the anticipated Day 1 visit date.
  21. Has participated in an investigational new drug trial during the 30 days prior to screening visit date, or within 5 half-lives of an investigational agent, whichever is longer.
  22. Has a confirmed diagnosis of malignancy within 5 years prior to 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 prior to screening may also be eligible if approved following discussion with the Sponsor's Medical Monitor. Patients under evaluation for malignant disease currently are not eligible for study participation.
  23. Patients who are unable to undergo MRI studies, whatever the reason for this, e.g. claustrophobia, the presence of a device or implant that would make imaging dangerous for the patient.
  24. Any other condition which, 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.

Sites / Locations

  • Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai KlinikaRecruiting
  • West Health Kft.,Recruiting
  • Krakowskie Centrum Medyczne sp z o.o.Recruiting
  • ID Clinic Arkadiusz PisulaRecruiting
  • Warsaw IBD Point Profesor KierkusRecruiting
  • Centrum Medyczne K2J2Recruiting
  • Centrum Badan Klinicznych Piotr Napora lekarzeRecruiting
  • Hospital Universitari Vall d HebronRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Universitario Virgen del Rocio (HUVR)Recruiting
  • Consorcio Hospital General Universitario de ValenciaRecruiting
  • Hospital Clnico Universitario de ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

FM101 150 mg BID

FM101 300 mg BID

Arm Description

orally administer placebo BID for 13 weeks except on Day 91 subject receive a single dose

orally administer FM101 150mg BID for 13 weeks except on Day 91 subject receive a single dose

orally administer FM101 300mg BID for 13 weeks except on Day 91 subject receive a single dose

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
To assess the treatment effect of FM101 on serum ALT concentrations during 13 weeks of treatment
Changes in serum ALT level

Secondary Outcome Measures

To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging-magnetic resonance elastography (MRI MRE) in patients with NAFLD or NASH
Change in liver stiffness on MRE

Full Information

First Posted
September 7, 2020
Last Updated
June 29, 2022
Sponsor
Future Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04710524
Brief Title
FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
Official Title
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Future Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Keywords
Nonalcoholic Fatty Liver Disease, NAFLD, Nonalcoholic Steatohepatitis, NASH, FM101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
orally administer placebo BID for 13 weeks except on Day 91 subject receive a single dose
Arm Title
FM101 150 mg BID
Arm Type
Experimental
Arm Description
orally administer FM101 150mg BID for 13 weeks except on Day 91 subject receive a single dose
Arm Title
FM101 300 mg BID
Arm Type
Experimental
Arm Description
orally administer FM101 300mg BID for 13 weeks except on Day 91 subject receive a single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID for 13 weeks
Intervention Type
Drug
Intervention Name(s)
FM101 150 mg BID
Intervention Description
FM101 (150 mg) BID for 13 weeks
Intervention Type
Drug
Intervention Name(s)
FM101 300 mg BID
Intervention Description
FM101 (300 mg) BID for 13 weeks
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH
Description
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
Time Frame
Day 1 through Day 106
Title
To assess the treatment effect of FM101 on serum ALT concentrations during 13 weeks of treatment
Description
Changes in serum ALT level
Time Frame
Day 1 through Day 91
Secondary Outcome Measure Information:
Title
To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging-magnetic resonance elastography (MRI MRE) in patients with NAFLD or NASH
Description
Change in liver stiffness on MRE
Time Frame
Day 1 through Day 91

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals must meet all of the following criteria to be included in the study: Be able and willing to provide written informed consent to take part in the study, and to comply with all the study's requirements. Be a man or woman ≥18 years of age at screening. Have c. 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 d. NAFLD based upon demonstration of at least 3 of the following 5 components of the metabolic syndrome below, at screening: Fasting plasma glucose ≥100 mg/dL , or undergoing drug treatment for elevated plasma glucose concentrations High-density lipoprotein-cholesterol (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 Serum ALT concentration >1 × upper limit of normal (ULN) at screening Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period. Undergo MRE with a score ≥2.9 kPa during the screening period. Women of childbearing potential (WoCBP) must have a negative serum beta human chorionic gonadotropin (HCG) test result at screening. Female patients must agree to use 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, but not limited to: Combined estrogen- and progestogen-containing hormonal contraception (oral, intravaginal and transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable); Intrauterine device, intrauterine hormone-releasing system, bilateral tubal, occlusion ('tubal occlusion' includes 'tubal ligation'); Vasectomized partner (only in the event that the vasectomized partner is the sole sexual partner of the WoCBP); Sexual abstinence (defined as refraining from heterosexual intercourse) only in the event that this is the preferred lifestyle of the patient. Childbearing potential is defined as being fertile following 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. Be willing to maintain a stable diet, including alcohol intake this applies, and physical activity throughout the entire study. Exclusion Criteria: Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study: 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. Female persons who are pregnant, or are breastfeeding at screening, or who plan to become pregnant during the study. Body mass index (BMI) <25 kg/m2. Fibrosis-4 index (FIB-4) >2.6 at screening. Any of the following laboratory test abnormalities at screening: Serum ALT and/or AST concentration >5 × upper limit of normal (ULN) Total serum bilirubin (BR) concentration >ULN; if an established diagnosis of Gilbert's syndrome exists and the direct serum BR result at screening is less than or equal to ULN the patient may participate in the study Serum albumin concentration ≤3.5 g/dL International normalized ratio (INR) ≥1.3 Platelet count less than the lower limit of normal range (LLN) Creatinine clearance rate <60 mL/minute as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation Positive COVID-19 polymerase chain reaction (PCR) test result at screening NOTE: Repeat testing of a given parameter or parameters that returned ineligible results, may be performed during the same screening period in consultation with the sponsor's Medical Monitor. An interval of at least 7 days should exist between receipt of the ineligible test result and re-testing. Chronic liver disease other than confirmed or suspected NASH, including but not limited to the following diagnoses / entities: Chronic hepatitis B virus infection (defined by the presence of hepatitis B surface antigen at screening) and / or chronic hepatitis C virus (HCV) infection (defined by the presence of detectable HCV ribonucleic acid (RNA) antibody [anti-HCV] at screening). Patients whose anti-HCV antibody test at screening is positive, but who test negative for HCV RNA at screening will be permitted to participate in the study as long as there has been evidence of viral negativity for at least 24 months prior to screening) Autoimmune hepatitis (AIH), or confirmed overlap syndrome of AIH and either primary biliary cholangitis or primary sclerosing cholangitis. Primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis whatever the basis for this, e.g. chronic pancreatitis resulting in bile duct stricture formation, recurrent extrahepatic bile duct calculus formation, arterial insult resulting in bile duct stricture formation Wilson's disease, homozygous alpha-1-anti-trypsin deficiency, hemochromatosis, drug-induced liver disease Alcoholic liver disease Suspected or confirmed hepatocellular carcinoma Medical, histologic, and/or imaging history of hepatic cirrhosis. Clinical, endoscopic, imaging and/or laboratory manifestations of portal hypertension, such as spider nevi, splenomegaly, clinically evident ascites formation, non-bleeding gastro-oesophageal varices. Known history of human immunodeficiency virus (HIV) infection. Chronic use (≥12 months) of any drug known to be associated with development of NAFLD during the five years before the anticipated Day 1 visit date, e.g. 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, e.g. minocycline. Use of the following medications: GLP-1 agonists, unless on a stable dose for at least 3 months prior to screening Thiazolidinediones, obeticholic acid or vitamin E at a daily dose >400 IU daily within the 6 months before screening Statin therapy and other lipid-modifying therapies must have been used at a stable dose for ≥3 months prior to screening Oral antidiabetic medication(s) (other than those specifically excluded) must have been used / taken at a stable daily dose for ≥3 months prior to screening 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 prior to 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. Active substance abuse within the 1 year before the screening visit date, upon the judgement of the investigator. Weight change ≥7% within the 6 months prior to screening or ≥5% within the 3 months prior to screening. Prior or planned (during the study period) weight reduction surgery, e.g. sleeve gastrectomy, Roux-en-Y gastrojejunostomy. Type 1 diabetes mellitus by medical history. Poorly controlled type 2 diabetes mellitus (this is defined as hemoglobin A1c (HbA1c) >9.5% at screening, or a patient whose oral anti-diabetic medication dosing requires adjustment >10% less than 2 months before the screening visit date. Uncontrolled systemic hypertension (either treated or untreated) defined as systolic blood pressure >160 mmHg or a diastolic blood pressure >100 mmHg 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. 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, e.g. unstable angina, acute coronary syndrome, myocardial infarction, cerebrovascular accident [stroke], cerebrovascular ischemia, transient ischemic attack, and / or peripheral vascular disease requiring intervention. 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 prior to the anticipated Day 1 visit date. Has participated in an investigational new drug trial during the 30 days prior to screening visit date, or within 5 half-lives of an investigational agent, whichever is longer. Has a confirmed diagnosis of malignancy within 5 years prior to 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 prior to screening may also be eligible if approved following discussion with the Sponsor's Medical Monitor. Patients under evaluation for malignant disease currently are not eligible for study participation. Patients who are unable to undergo MRI studies, whatever the reason for this, e.g. claustrophobia, the presence of a device or implant that would make imaging dangerous for the patient. Any other condition which, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saehan Kang, MS
Phone
+82232873805
Email
saehan@futuremedicine.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Kyounghee Kim, MS
Phone
+8222898540
Email
kkh@futuremedicine.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WanSeok Jeong, MBA
Organizational Affiliation
Future Medicine Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klára Werling, Dr.
Facility Name
West Health Kft.,
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tibor Gyökeres, Dr.
Facility Name
Krakowskie Centrum Medyczne sp z o.o.
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Rozpondek
Facility Name
ID Clinic Arkadiusz Pisula
City
Mysłowice
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Janczewska
Facility Name
Warsaw IBD Point Profesor Kierkus
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Kierkus
Facility Name
Centrum Medyczne K2J2
City
Wołomin
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof Kuc
Facility Name
Centrum Badan Klinicznych Piotr Napora lekarze
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof Simon
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Manuel Pericas
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Crespo Garcia
Facility Name
Hospital Universitario Virgen del Rocio (HUVR)
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Romero-Gomez
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moises Diago Madrid
Facility Name
Hospital Clnico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Desamparados Escudero-Garcia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

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