NAFLD with hypertriglyceridemia NAFLD
Conditions
Interventions
1. Pemafibrate high dose group
Palmodia 0.1 mg tablets are orally administered twice daily, 2 tablets at a time, after breakfast and dinner.
If unavoidable,Pemafibrate extended-release 0.2 mg two tabl
Sponsors
Iwaki Michihiro
Kessoku Takaomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients whose ages are between 20 and 80 years old at the time of obtaining consent. 2.Patients with fatty liver diagnosed by histological examination within 1 year prior to obtaining consent, or by imaging examination within 6 months prior to obtaining consent, and who have not responded to exercise or diet therapy for more than 3 months 3. Patients with hypertriglyceridemia (150-500 mg / dl) within 91 days before obtaining consent. 4. Patients with high ALT (male 43-100 IU / L, female 24-100 IU / L) within 91 days before obtaining consent. 5.Patients whose daily drinking amount is less than 30 g per day for men and less than 20 g for women in terms of ethanol at the time of obtaining consent 6.Patients who do not have other liver diseases such as hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis, and primary biliary cholangitis at the time of consent acquisition 7. Patients with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Taking cyclosporine, rifampicin, amiodarone, and breast cancer treatments (tamoxifen, toremifene, raloxifene). 2. Patients with BMI normal upper limit x2 within 91 days before obtaining consent excluding Girbert syndrome. 6. Platelet count 9.5 % within 91 days prior to obtaining consent. 15. Patients with psychosis, alcoholism, drug addiction, or drug addiction that may affect compliance with the research plan. 16. Patients who participated in other clinical trials 100 days before obtaining consent. 17. Pregnant women or patients who may be pregnant. 18. Patients with malignant tumor. However, patients who have undergone radical surgery or who have completed administration of anticancer drugs are allowed to be registered, and patients who are being observed and evaluated for malignant tumors are excluded. 19. Patients who are considered inappropriate to participate in this study by the reseacher. 20. Patients who have received concomitant medications for more than 1 week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ALT after 24-week administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in ALT after 48 weeks of administration 2) Amout of change and rates of change in liver fibrosis markers after 48 weeks of administration. 3) AST, GGT, Cr, BUN, HbA1c, platelets, HOMA-IR, HDL-C, non-HDL-C, LDL-C / HDL-C ratio, TG from baseline to 24 and 48 weeks. Amount of change and rate of change ALT from baseline to 24 and 48 weeks. Amount of change and rate of change 4) (Only for facilities where MRE and USE can be performed) Amount of change and rate of change in liver fat and liver hardness from baseline in MRE and USE. 5) Presence or absence of cardiovascular events, liver disease-related events, and carcinogenesis during the intervention period / observation period 6) Changes in body weight, BMI, and abdominal circumference from baseline at 24 and 48 weeks of administration 7) Changes in 10-year ASCVD (Atherosclerotic Cardiovascular Disease) risk score 8) Percentage of patients with ALT 100 IU / L or higher and / or more than double that at week 0 9) Safety (incidence of AEs and ADRs at 48 weeks of treatment) | — |
Contacts
Public ContactMichihiro Iwaki
Yokohama City University Hospital
Outcome results
None listed