Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

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 \"fatty liver is present on histology or imaging\" regarding NAFLD definition.
• •3） 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.
• •4） 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.
• •5） 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.