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.

Kowa Company, Ltd.16 sites in 1 country118 target enrollmentDecember 27, 2017

ConditionsNon-Alcoholic Fatty Liver Disease

InterventionsK-877 Placebo

DrugsK-877 Placebo

Overview

Phase: Phase 2
Intervention: K-877
Conditions: Non-Alcoholic Fatty Liver Disease
Sponsor: Kowa Company, Ltd.
Enrollment: 118
Locations: 16
Primary Endpoint: Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 27, 2017

End Date

June 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kowa Company, Ltd.

Responsible Party

Sponsor

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
•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）

Arms & Interventions

Treatment Group

K-877 (pemafibrate) tablet twice daily.

Intervention: K-877

Control Group

placebo tablet twice daily.

Intervention: Placebo

Outcomes

Primary Outcomes

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

Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug

Time Frame: Week 24

Secondary Outcomes

Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa)(From baseline upto week 72)
Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, γ-GTP in IU/L)(From baseline upto week 72)
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)
Change in noninvasive biomarkers (NAFLD fibrosis score)(From baseline upto week 72)
Change in noninvasive biomarkers (FIB4 index)(From baseline upto week 72)
Change in noninvasive biomarkers (NAFIC score)(From baseline upto week 72)
Change in noninvasive biomarkers (ELF test)(From baseline upto week 72)
Percentage of patients with ≥ 30% reduction in hepatic fat fraction (MRI-PDFF)(From baseline upto week 72)
Percentage of patients with ≥ 15% reduction in liver stiffness (MRE)(From baseline upto week 72)