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

Kowa

Status and phase: Completed; Phase 2

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Drug: Placebo; Drug: K-877

Study type: Interventional

Funder types: Industry

Identifiers

NCT03350165

K-877-FL-01

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

K-877 (pemafibrate) tablet twice daily.

Treatment:

Drug: K-877

Control Group

Placebo Comparator group

Description:

placebo tablet twice daily.

Treatment:

Drug: Placebo