Patients with dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Conditions
Interventions
pemafibrate 0.1mg x2/day, max 0.2mg x2/day, 48 weeks.
Sponsors
Shinshu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fasting triglyceride > 150 mg/dL, or LDL-C > 140 mg/dL, or HDL-C < 40mg/dL. 2. NAFLD with ALT > 40 U/L 3. Good activity of daily life and NO serious diseases 4. NO renal dysfunction 5. Agreement not to change daily activity and medications markedly 6. Agreement to undergo regular examination and medications 7. Agreement to participate in this trial by oneself
Exclusion criteria
Exclusion criteria: 1. Creatinine > 1.5 mg/dL 2. Past history of myopathy and renal dysfunction by fibrate drugs 3. During Pregnancy and breast-feeding 4. Humans who were judged as not-suitable for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in liver enzymes at 24 and 48 weeeks after commencing the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in liver fat/visceral fat calculated by CT and blood lipid, glucose, inflammation markers | — |
Countries
Japan
Contacts
Public ContactNaoki Tanaka
Shinshu University School of Medicine Department of Metabolic Regulation
Outcome results
None listed