Hypertgemia
Conditions
Interventions
Group A: administer pemafibrate of 0.2 mg/day for 24 weeks
Group B: administer omega-3 fatty acid ethyl esters of 2 g/day for 24 weeks
Sponsors
Sumida Yoshio
Yoneda Masashi
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are included in this study: 1. Subjects whose fasting TG is 150 mg/dL or higher and less than 500 mg/dL within 12 weeks before giving their consent. 2. Subjects who are diagnosed as steatosis by abdominal ultrasound test within 6 months before giving their consent. 3. Male subjects whose ALT is higher than 40 IU/L or female subjects whose ALT is higher than 30 IU/L within 12 weeks before giving their consent. 4. Male and female aged 20 years or older 5. Subjects who give their consent in a written form
Exclusion criteria
Exclusion criteria: Subjects who fall into any of the following criteria are excluded from participating in the study: 1.Subjects whose ALT is 250 IU/L or higher 2. Subjects who are excessive drinkers (male subjects whose ethanol intake is 210 g/week or more, or female subjects whose ethanol intake is 140 g/week) 3. Subjects who use fibrates within 12 weeks before giving their consenting 4. Subjects who use omega-3 fatty acid agents or relevant supplements within 6 months before giving their consenting 5. Subjects who use prohibited drugs in this study (pioglitazone, vitamin E, SGLT2 inhibitors, GLP-1 receptor antagonists, study agent, control agent, or any drugs or supplements with the same indications) within 12 weeks before giving their consenting 6. Subjects whose BMI is less than 22 kg/m2 7. Subjects with unstable glycemic control (HbA1c within 12 weeks before giving their consent months is 8% or higher) 8. Subjects with hepatic cirrhosis 9. Subjects whose plasma creatinine is 1.5 mg/dL or higher 10. Subjects with cholelithiasis or biliary obstruction 11. Subjects who have chronic liver diseases with the following steatosis except NAFLD i) viral hepatitis (hepatitis B, hepatitis C) ii) autoimmune hepatitis (AIH) iii) primary biliary cholangitis (PBC) iv) primary sclerosing cholangitis (PSC) v) drug-induced liver injury vi) endocrine/metabolic hepatitis (hyperthyroidism, Wilson disease, hemochromatosis, or alpha1-antitrypsin deficiency) 12. Patients with malignant tumor or patients who are expected to have any recurrence of malignant tumor after the amelioration 13. Patients who underwent blood collection or blood donation of 200 mL or more within 12 weeks before giving their consent 14. Patients with history of severe drug hypersensitivity (such as anaphylactic shock) 15. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant 16. Patients who are participating in other interventional trials 17. Patients with history of hypersensitivity to, or who meet contraindication for the study agent or the control agent in this study 18. Patients who need legal representative for giving consent 19. Patients who are considered to be unsuitable for participating in this study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ALT from baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Percent change in ALT from baseline to week 24 ii. Change and percent change in ALT from baseline to week 4 or week 12 iii. Change and percent change in the following items from baseline to each observation point (items marked with * are evaluated by both change and percent change.) - Body weight, BMI, waist circumference - Blood pressure (diastolic blood pressure / systolic blood pressure, office blood pressure at sitting position) - Lipd biomarkers (TG, TC, LDL-C, HDL-C, non-HDL-C) - Hepatic biomarkers (AST*, gamma-GTP, type IV collagen 7S, M2BPGi, Fib4 index*) - Inflammation biomarker (hsCRP) - glucose metabolism biomarkers (HbA1c, fasting plasma glucose, insulin) - CT (L/S ratio) (optional) - liver stiffness (VTQ / Virtual Touch Quantification) (optional) - MRI (liver fat content, liver stiffness) (optional) - other general biochemical tests (platelet count, total protein, albumin, A/G ratio, urea nitrogen, uric acid, creatinine, eGFR, total bilirubin, lactic acid, pyruvic acid, direct bilirubin, LDH, ALP, ChE) iv. Frequency of adverse events or diseases or the like | — |
Contacts
Public ContactYoshio Sumida
Aichi Medical University Hospital
Outcome results
None listed