Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06623539
PHASE2

Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

Sponsor: Yokohama City University

View on ClinicalTrials.gov

Summary

This is a study to evaluate the effect of pemafibrate on fatty liver in patients with hypertgemia combined with NAFLD, using fenofibrate as a control.

Official title: Pemafibrate for Treating NAFLD Complicated by Hypertriglyceridemia: A Multi-center, Open Study, Randomized Controlled Trial (PRESENT Study)

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2020-12-23

Completion Date

2026-03

Last Updated

2024-10-02

Healthy Volunteers

No

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.

Locations (1)

Yokohama city university

Yokohama, Kanagawa, Japan