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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
K-877
Placebo
Sponsored by
Kowa Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

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

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
  9. Those with complicating malignant neoplasm or those judged to be at a high risk of recurrence
  10. Patients with contraindications to MRI imaging
  11. 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
  12. Patients with a history of serious drug allergies (such as anaphylactic shock)
  13. Pregnancy, breast feeding, planned pregnancy
  14. 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
  15. Patients who have previously been administered pemafibrate
  16. Patients who have been determined inappropriate by the investigator or subinvestigator

Sites / Locations

  • Aomori Prefectural Central Hospital
  • Asahikawa Medical University
  • Fukuwa Clinic
  • Fukuoka University Hospital
  • SeireiHamamatsu General Hospital
  • Hamamatsu University Hospital
  • Iwata City Hospital
  • Chutoen General Medical Center
  • Kurume University Hospital
  • Niigata University Medical & Dental Hospital
  • Ogaki Municipal Hospital
  • Shiga University of Medical Science Hospital
  • Hokkaido University Hospital
  • Yamagata University Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Yokohama City University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm Description

K-877 (pemafibrate) tablet twice daily.

placebo tablet twice daily.

Outcomes

Primary Outcome Measures

Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug

Secondary Outcome Measures

Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa)
Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, γ-GTP in IU/L)
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)
Change in noninvasive biomarkers (NAFLD fibrosis score)
Change in noninvasive biomarkers (FIB4 index)
Change in noninvasive biomarkers (NAFIC score)
Change in noninvasive biomarkers (ELF test)
Percentage of patients with ≥ 30% reduction in hepatic fat fraction (MRI-PDFF)
Percentage of patients with ≥ 15% reduction in liver stiffness (MRE)

Full Information

First Posted
November 9, 2017
Last Updated
April 8, 2021
Sponsor
Kowa Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03350165
Brief Title
A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Company, Ltd.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
K-877 (pemafibrate) tablet twice daily.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
placebo tablet twice daily.
Intervention Type
Drug
Intervention Name(s)
K-877
Other Intervention Name(s)
pemafibrate
Intervention Description
0.2mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
K-877 matching placebo tablet
Primary Outcome Measure Information:
Title
Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time Frame
Week 24
Title
Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa)
Time Frame
From baseline upto week 72
Title
Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, γ-GTP in IU/L)
Time Frame
From baseline upto week 72
Title
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)
Time Frame
From baseline upto week 72
Title
Change in noninvasive biomarkers (NAFLD fibrosis score)
Time Frame
From baseline upto week 72
Title
Change in noninvasive biomarkers (FIB4 index)
Time Frame
From baseline upto week 72
Title
Change in noninvasive biomarkers (NAFIC score)
Time Frame
From baseline upto week 72
Title
Change in noninvasive biomarkers (ELF test)
Time Frame
From baseline upto week 72
Title
Percentage of patients with ≥ 30% reduction in hepatic fat fraction (MRI-PDFF)
Time Frame
From baseline upto week 72
Title
Percentage of patients with ≥ 15% reduction in liver stiffness (MRE)
Time Frame
From baseline upto week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients show presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at Screening Patients show presence of liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening Patients have an ALT above the upper limits of normal (30 IU/L for females and 40 IU/L for males) at Screening Patients with NAFLD had to be age 20 years or older at written informed consent(ICF) Exclusion Criteria: 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) Planned use of Contraindicated Medications from written ICF to end of treatment. BMI < 22 kg/m2 at Screening Uncontrolled diabetes mellitus as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening eGFR < 30 mL/min/1.73m2 or Dialysis patient Cirrhosis Biliary obstruction 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 Those with complicating malignant neoplasm or those judged to be at a high risk of recurrence Patients with contraindications to MRI imaging 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 Patients with a history of serious drug allergies (such as anaphylactic shock) Pregnancy, breast feeding, planned pregnancy 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 Patients who have previously been administered pemafibrate Patients who have been determined inappropriate by the investigator or subinvestigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryohei Tanigawa
Organizational Affiliation
Clinical Development Dept. Ⅰ
Official's Role
Study Director
Facility Information:
Facility Name
Aomori Prefectural Central Hospital
City
Aomori, Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Asahikawa Medical University
City
Asahikawa, Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku, Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
SeireiHamamatsu General Hospital
City
Hamamatsu, Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu, Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Iwata City Hospital
City
Iwata, Shizuoka
ZIP/Postal Code
438-8550
Country
Japan
Facility Name
Chutoen General Medical Center
City
Kakegawa, Shizuoka
ZIP/Postal Code
436-8555
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume, Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata, Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki, Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu, Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo, Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata, Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Yokohama, Kanagawa
ZIP/Postal Code
230-8765
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama, Kanagawa
ZIP/Postal Code
236-0004
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34528723
Citation
Nakajima A, Eguchi Y, Yoneda M, Imajo K, Tamaki N, Suganami H, Nojima T, Tanigawa R, Iizuka M, Iida Y, Loomba R. Randomised clinical trial: Pemafibrate, a novel selective peroxisome proliferator-activated receptor alpha modulator (SPPARMalpha), versus placebo in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2021 Nov;54(10):1263-1277. doi: 10.1111/apt.16596. Epub 2021 Sep 16.
Results Reference
derived
PubMed Identifier
33392801
Citation
Fruchart JC, Hermans MP, Fruchart-Najib J, Kodama T. Selective Peroxisome Proliferator-Activated Receptor Alpha Modulators (SPPARMalpha) in the Metabolic Syndrome: Is Pemafibrate Light at the End of the Tunnel? Curr Atheroscler Rep. 2021 Jan 3;23(1):3. doi: 10.1007/s11883-020-00897-x.
Results Reference
derived

Learn more about this trial

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

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