Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

NCT06623539 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: jRCTs031200280
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pemafibrate; Fenofibrate

Outcome Measures

Primary Outcomes (1)

• Change in ALT level

  24 weeks

Study Arms (3)

Pemafibrate high dose group

EXPERIMENTAL

Drug: Pemafibrate high dose

Pemafibrate low dose group

EXPERIMENTAL

Drug: Pemafibrate low dose

Fenofibrate group

EXPERIMENTAL

Drug: Fenofibrate

Interventions

Pemafibrate high dose DRUG

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.

Pemafibrate high dose group

Pemafibrate low dose DRUG

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.

Pemafibrate low dose group

Fenofibrate DRUG

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.

Fenofibrate group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women at least 20 years old and under 80 years old at the time of obtaining consent.
• Patients with fatty liver diagnosed histologically within 1 year prior to obtaining consent or imaging examination within 6 months prior to obtaining consent and who have failed exercise and diet therapy for at least 3 months.
• Patients with hypertriglyceridemia (150-500 mg/dl) within 91 days prior to obtaining consent.
• Patients with elevated ALT (43-100 IU/L for men, 24-100 IU/L for women) within 91 days prior to obtaining consent.
• Patients whose daily alcohol consumption (ethanol equivalent) is less than 30 grams per day for men and less than 20 grams per day for women at the time of obtaining consent.
• Patients with hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis, primary biliary cholangitis, or other hepatic complications that have been ruled out at the time of obtaining consent.
• Patients whose written consent to participate in this study has been obtained. \[Basis for settings\]
• ） The age range was set to 20 years or older because the safety of the study drug has not been established in children. In addition, the age of patients was set to be less than 80 years considering safety and the susceptible age of NAFLD/NASH onset.
• ） This is because the 2014 NAFLD/NASH guideline states that \"fatty liver is present on histology or imaging\" regarding NAFLD definition.
• ） Within dyslipidemia patients, those with hypertriglyceridemia and indicated for fibrates will be used as controls.
• Since TG\>500 poses a risk of developing acute pancreatitis, the selection criteria were TG levels between 150 and 500 mg/dl.
• ） Since the primary endpoint in this study was the amount of change in ALT, elevated ALT was used as the selection criterion in the JCCLS shared reference value range so that changes could be better understood. ALT was specifically set as the upper limit of normal to 100 IU/L in the selection criteria based on the package insert of fenofibrate.
• ） NAFLD diagnostic criteria from the 2014 NAFLD/NASH guidelines were cited. 6） NAFLD diagnostic criteria from the 2014 NAFLD/NASH guidelines were cited. 7） This was set to ensure the free and voluntary participation of the study participants.

You may not qualify if:

• Patients taking contraindications (see \"6.5.2.2 Contraindicated treatments\").
• Cyclosporine, rifampicin, steroids (excluding topical and inhaled drugs), amiodarone, breast cancer drugs (tamoxifen, toremifene, raloxifene).
• Patients with BMI \<18.5 kg/m2 at the time of obtaining consent.
• Patients who have been diagnosed with liver cirrhosis at the time of obtaining consent.
• Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy, splenomegaly) at the time of obtaining consent.
• Patients with T-Bil \> 2× the upper limit of normal within 91 days prior to obtaining consent, excluding Girbert syndrome.
• Platelet count \<80,000/μL within 91 days prior to obtaining consent.
• Serum Cr level of 1.5 mg/dL or higher within 91 days prior to obtaining consent.
• Patients with gallstones or biliary obstruction at the time of obtaining consent.
• Patients with severe infection, pre- or post-operative, or severe trauma at the time of obtaining consent.
• Patients who have used fibrates within 91 days prior to obtaining consent
• Patients with 10% weight change in 91 days prior to obtaining consent
• Patients who have undergone bariatric surgery or are scheduled for surgery during the study period
• Patients with a history of type I diabetes mellitus
• Patients with HbA1c \>9.5% within 91 days prior to obtaining consent (If HbA1c \>9.5%, re-entry will be possible after improvement by treatment.)

Sponsors & Collaborators

• Yokohama City University: lead

Study Sites (1)

Yokohama city university

Yokohama, Kanagawa, 236-0004, Japan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid; Fenofibrate

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michihiro Iwaki

Model Details: Multicenter, open-label, three-arm, randomized controlled trial

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: December 23, 2020
• Primary Completion: June 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)