Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

December 23, 2020

Primary Completion Date

June 30, 2025

Study Completion Date

March 31, 2026

Conditions
Non Alcoholic Fatty Liver Disease
Interventions
DRUG

Pemafibrate high dose

Pemafibrate 0.1 mg tablets shall be administered orally twice daily, two tablets per dose, after the morning and evening meals. If unavoidable, pemafibrate extended-release 0.2 mg for 2 tablets 1 or 0.4 mg for 1 tablet 1 can be substituted.

DRUG

Pemafibrate low dose

Pemafibrate 0.1 mg tablets shall be administered orally twice daily, one tablet per dose, after the morning and evening meals. If unavoidable, pemafibrate extended-release 0.2 mg for 1 tablets 1 can be substituted.

DRUG

Fenofibrate

Fenofibrate 53.3 mg tablets shall be administered orally once daily, one tablet per dose, after breakfast. Thereafter, the dose may be carefully increased to two tablets per dose at the physician\'s discretion.

Trial Locations (1)

236-0004

Yokohama city university, Yokohama

All Listed Sponsors
lead

Yokohama City University

OTHER