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

Non-Alcoholic Fatty Liver Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350165
• Other study ID #: K-877-FL-01
• Status: Completed
• Phase: Phase 2
• Start date: December 27, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2021
• Source: Kowa Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 30, 2020
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• K-877
0.2mg tablet
• Placebo
K-877 matching placebo tablet

Locations

Country	Name	City	State
Japan	Aomori Prefectural Central Hospital	Aomori, Aomori
Japan	Asahikawa Medical University	Asahikawa, Hokkaido
Japan	Fukuwa Clinic	Chuo-ku, Tokyo
Japan	Fukuoka University Hospital	Fukuoka, Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu, Shizuoka
Japan	SeireiHamamatsu General Hospital	Hamamatsu, Shizuoka
Japan	Iwata City Hospital	Iwata, Shizuoka
Japan	Chutoen General Medical Center	Kakegawa, Shizuoka
Japan	Kurume University Hospital	Kurume, Fukuoka
Japan	Niigata University Medical & Dental Hospital	Niigata, Niigata
Japan	Ogaki Municipal Hospital	Ogaki, Gifu
Japan	Shiga University of Medical Science Hospital	Otsu, Shiga
Japan	Hokkaido University Hospital	Sapporo, Hokkaido
Japan	Yamagata University Hospital	Yamagata, Yamagata
Japan	Saiseikai Yokohamashi Tobu Hospital	Yokohama, Kanagawa
Japan	Yokohama City University Hospital	Yokohama, Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Company, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)		Week 24
Primary	Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug		Week 24
Secondary	Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa)		From baseline upto week 72
Secondary	Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, ?-GTP in IU/L)		From baseline upto week 72
Secondary	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
Secondary	Change in noninvasive biomarkers (NAFLD fibrosis score)		From baseline upto week 72
Secondary	Change in noninvasive biomarkers (FIB4 index)		From baseline upto week 72
Secondary	Change in noninvasive biomarkers (NAFIC score)		From baseline upto week 72
Secondary	Change in noninvasive biomarkers (ELF test)		From baseline upto week 72
Secondary	Percentage of patients with = 30% reduction in hepatic fat fraction (MRI-PDFF)		From baseline upto week 72
Secondary	Percentage of patients with = 15% reduction in liver stiffness (MRE)		From baseline upto week 72