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Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

NCT06623539 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-10-02

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Yokohama City University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2025-06-30
Completion
2026-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623539 on ClinicalTrials.gov