NCT06623539

Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Yokohama City University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-23
• Primary completion: 2025-06-01
• Completion: 2026-03-01
• First posted: 2024-10-02
• Last updated: 2024-10-02

Locations

1 site across 1 country: Japan