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

NCT ID: NCT03350165

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-27
• Study Completion Date: 2020-06-30

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group

K-877 (pemafibrate) tablet twice daily.

Group Type: EXPERIMENTAL

K-877

Intervention Type: DRUG

0.2mg tablet

Control Group

placebo tablet twice daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

K-877 matching placebo tablet

Interventions

K-877

0.2mg tablet

Intervention Type: DRUG

Placebo

K-877 matching placebo tablet

Intervention Type: DRUG

Other Intervention Names

pemafibrate

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Company, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryohei Tanigawa

Role: STUDY_DIRECTOR

Clinical Development Dept. Ⅰ

Locations

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

SeireiHamamatsu General Hospital

Hamamatsu, Shizuoka, , Japan

Hamamatsu University 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, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 34528723 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33392801 (View on PubMed)

Other Identifiers

K-877-FL-01

Identifier Type: -

Identifier Source: org_study_id