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Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease | Clinical Trials | Clareo Health

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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)

NCT06623539•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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women at least 20 years old and under 80 years old at the time of obtaining consent.
•2. 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.
•3. Patients with hypertriglyceridemia (150-500 mg/dl) within 91 days prior to obtaining consent.
•4. Patients with elevated ALT (43-100 IU/L for men, 24-100 IU/L for women) within 91 days prior to obtaining consent.
•5. 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.
•6. 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.
•7. Patients whose written consent to participate in this study has been obtained. \[Basis for settings\]
•1） 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.
•2） This is because the 2014 NAFLD/NASH guideline states that \&#34;fatty liver is present on histology or imaging\&#34; regarding NAFLD definition.
•3） Within dyslipidemia patients, those with hypertriglyceridemia and indicated for fibrates will be used as controls.
+3 more criteria

Exclusion Criteria

•1. Patients taking contraindications (see \&#34;6.5.2.2 Contraindicated treatments\&#34;).
•Cyclosporine, rifampicin, steroids (excluding topical and inhaled drugs), amiodarone, breast cancer drugs (tamoxifen, toremifene, raloxifene).
•2. Patients with BMI \&lt;18.5 kg/m2 at the time of obtaining consent.
•3. Patients who have been diagnosed with liver cirrhosis at the time of obtaining consent.
•4. Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy, splenomegaly) at the time of obtaining consent.
•5. Patients with T-Bil \&gt; 2× the upper limit of normal within 91 days prior to obtaining consent, excluding Girbert syndrome.
•6. Platelet count \&lt;80,000/μL within 91 days prior to obtaining consent.
•7. Serum Cr level of 1.5 mg/dL or higher within 91 days prior to obtaining consent.
•8. Patients with gallstones or biliary obstruction at the time of obtaining consent.
•9. Patients with severe infection, pre- or post-operative, or severe trauma at the time of obtaining consent.
+10 more criteria

Locations (1)

Yokohama city university

Yokohama, Kanagawa, Japan

Key Dates

Start Date

December 23, 2020

Primary Completion Date

June 1, 2025

Completion Date

March 1, 2026

Last Updated

October 2, 2024

Enrollment

360

ACTUAL participants

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

Pemafibrate high dose

DRUG

Pemafibrate low dose

DRUG

Fenofibrate

DRUG

Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

NCT07104786

Non Alcoholic Fatty Liver Disease

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UNKNOWNNA

Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity

NCT04442620

Non Alcoholic Fatty Liver Disease

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COMPLETEDNA

Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

Inclusion Criteria

Exclusion Criteria

Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity

Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population

Genetics of Fatty Liver Disease in Children

Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients