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A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Sponsor
Kowa Company, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03350165
Collaborator
(none)
118
Enrollment
16
Locations
2
Arms
30.1
Actual Duration (Months)
7.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.
Actual Study Start Date :
Dec 27, 2017
Actual Primary Completion Date :
Apr 3, 2019
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

K-877 (pemafibrate) tablet twice daily.

Drug: K-877
0.2mg tablet
Other Names:
  • pemafibrate

    		•
    Placebo Comparator: Control Group

    placebo tablet twice daily.

    Drug: Placebo
    K-877 matching placebo tablet

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [Week 24]

    2. Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug [Week 24]

    Secondary Outcome Measures

    1. Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa) [From baseline upto week 72]

    2. Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, γ-GTP in IU/L) [From baseline upto week 72]

    3. Change in noninvasive biomarkers (Cytokeratin 18 in U/L, Hyaluronic acid in ng/mL, Type IV collagen 7S in ng/mL, M2BPGi in no unit) [From baseline upto week 72]

    4. Change in noninvasive biomarkers (NAFLD fibrosis score) [From baseline upto week 72]

    5. Change in noninvasive biomarkers (FIB4 index) [From baseline upto week 72]

    6. Change in noninvasive biomarkers (NAFIC score) [From baseline upto week 72]

    7. Change in noninvasive biomarkers (ELF test) [From baseline upto week 72]

    8. Percentage of patients with ≥ 30% reduction in hepatic fat fraction (MRI-PDFF) [From baseline upto week 72]

    9. Percentage of patients with ≥ 15% reduction in liver stiffness (MRE) [From baseline upto week 72]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients show presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at Screening

    2. Patients show presence of liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening

    3. Patients have an ALT above the upper limits of normal (30 IU/L for females and 40 IU/L for males) at Screening

    4. Patients with NAFLD had to be age 20 years or older at written informed consent(ICF)

    Exclusion Criteria:

    1. Current of significant alcohol consumption (significant alcohol consumption is defined as more than 210 g/week in males and more than 140 g/week in females, on average)

    2. Planned use of Contraindicated Medications from written ICF to end of treatment.

    3. BMI < 22 kg/m2 at Screening

    4. Uncontrolled diabetes mellitus as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening

    5. eGFR < 30 mL/min/1.73m2 or Dialysis patient

    6. Cirrhosis

    7. Biliary obstruction

    8. Patients were excluded if they had evidence of other forms of liver disease shown by the following:

    • Hepatitis B or Hepatitis C

    • Autoimmune hepatitis（AIH）

    • Primary biliary cirrhosis（PBC）

    • Primary Sclerosing Cholangitis（PSC）

    • Drug-induced liver injury

    • hyperthyroidism, Wilson's disease, hemochromatosis, alpha-1-antitrypsin disease

    1. Those with complicating malignant neoplasm or those judged to be at a high risk of recurrence

    2. Patients with contraindications to MRI imaging

    3. Patients who gave 200 mL or more of blood within 1 month before the administration of the study drug, or 400 mL or more of blood within 4 months before the administration of the study drug

    4. Patients with a history of serious drug allergies (such as anaphylactic shock)

    5. Pregnancy, breast feeding, planned pregnancy

    6. Patients who were participating in another clinical study at the time of consent was obtained or who received study drugs other than the placebo less than 16 weeks before consent was obtained

    7. Patients who have previously been administered pemafibrate

    8. Patients who have been determined inappropriate by the investigator or subinvestigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aomori Prefectural Central Hospital Aomori, Aomori Japan 030-8553
    2 Asahikawa Medical University Asahikawa, Hokkaido Japan 078-8510
    3 Fukuwa Clinic Chuo-ku, Tokyo Japan 104-0031
    4 Fukuoka University Hospital Fukuoka, Fukuoka Japan 814-0180
    5 SeireiHamamatsu General Hospital Hamamatsu, Shizuoka Japan 430-8558
    6 Hamamatsu University Hospital Hamamatsu, Shizuoka Japan 431-3192
    7 Iwata City Hospital Iwata, Shizuoka Japan 438-8550
    8 Chutoen General Medical Center Kakegawa, Shizuoka Japan 436-8555
    9 Kurume University Hospital Kurume, Fukuoka Japan 830-0011
    10 Niigata University Medical & Dental Hospital Niigata, Niigata Japan 951-8520
    11 Ogaki Municipal Hospital Ogaki, Gifu Japan 503-8502
    12 Shiga University of Medical Science Hospital Otsu, Shiga Japan 520-2192
    13 Hokkaido University Hospital Sapporo, Hokkaido Japan 060-8648
    14 Yamagata University Hospital Yamagata, Yamagata Japan 990-9585
    15 Saiseikai Yokohamashi Tobu Hospital Yokohama, Kanagawa Japan 230-8765
    16 Yokohama City University Hospital Yokohama, Kanagawa Japan 236-0004

    Sponsors and Collaborators

    • Kowa Company, Ltd.

    Investigators

    • Study Director: Ryohei Tanigawa, Clinical Development Dept. Ⅰ

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kowa Company, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03350165
    Other Study ID Numbers:
    • K-877-FL-01
    First Posted:
    Nov 22, 2017
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Apr 9, 2021