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A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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.

NCT03350165•Kowa Company, Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

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）
+12 more criteria

Locations (16)

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

Key Dates

Start Date

December 27, 2017

Primary Completion Date

April 3, 2019

Completion Date

June 30, 2020

Last Updated

April 9, 2021

Enrollment

118

ACTUAL participants

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

K-877

DRUG

Placebo

DRUG

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

View study

RECRUITINGPHASE3

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

NCT07221227

Non-alcoholic Fatty Liver Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

Nonalcoholic Steatohepatitis in Chinese Children

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