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

NCT03350165 | Completed Phase 2

• 1 other identifier: K-877-FL-01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 16

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

Outcome Measures

Primary Outcomes (2)

• Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

  Week 24

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

  Week 24

Secondary Outcomes (9)

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

K-877 (pemafibrate) tablet twice daily.

Drug: K-877

Control Group

PLACEBO COMPARATOR

placebo tablet twice daily.

Drug: Placebo

Interventions

K-877 DRUG

0.2mg tablet

Also known as: pemafibrate

Treatment Group

Placebo DRUG

K-877 matching placebo tablet

Control Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (16)

Aomori Prefectural Central Hospital

Aomori, Aomori, 030-8553, Japan

Location

Asahikawa Medical University

Asahikawa, Hokkaido, 078-8510, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

SeireiHamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Iwata City Hospital

Iwata, Shizuoka, 438-8550, Japan

Location

Chutoen General Medical Center

Kakegawa, Shizuoka, 436-8555, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, Niigata, 951-8520, Japan

Location

Ogaki Municipal Hospital

Ogaki, Gifu, 503-8502, Japan

Location

Shiga University of Medical Science Hospital

Otsu, Shiga, 520-2192, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Yamagata University Hospital

Yamagata, Yamagata, 990-9585, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 230-8765, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Related Publications (2)

• 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.

  PMID: 34528723 DERIVED

• 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.

  PMID: 33392801 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

K-877 compound; (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Ryohei Tanigawa

  Clinical Development Dept. Ⅰ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 22, 2017
• Study Start: December 27, 2017
• Primary Completion: April 3, 2019
• Study Completion: June 30, 2020
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

JP (16)