MetALD complicated with dyslipidemia
Conditions
Interventions
Patients will be administered 0.2 mg or 0.4 mg of pemafibrate (Palmodia XR) for 48 weeks, and will be evaluated every 8 weeks through medical examinations and blood sampling. Evaluation of liver fibro
Sponsors
Juntendo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 or over at the point of obtaining consent. Those who have been diagnosed with hepatic steatosis by either diagnostic imaging or liver biopsy, and who fulfill at least one of the following five criteria (BMI>23 or waist circumference (men > 94 cm, women > 80 cm), Fasting blood glucose>100 mg/dL or 2-hour post-load blood glucose >140 mg/dL or HbA1c >5.7% or diagnosed or being treated for type 2 diabetes. Blood pressure >130/85 mmHg or being treated with medication for hypertension. TG >150 mg/dL or being treated for dyslipidemia. HDL-C is <40 mg/dL in men and <50 mg/dL in women, or you are being treated for dyslipidemia. Those who have a habit of consuming alcohol (alcohol consumption of 210 g or more but less than 420 g of ethanol per week for men, and 140 g or more but less than 350 g of ethanol per week for women) at the time of obtaining consent The diagnosis of hyperlipidemia is based on the 2022 edition of the guidelines for the prevention of arteriosclerotic diseases (fasting serum TG of 150 mg/dL or more, or random serum TG of 175 mg/dL or more) After receiving sufficient explanation regarding participation in this study, the research subject has provided written consent of their own free will with a full understanding of the study.
Exclusion criteria
Exclusion criteria: Patients with a FIB-4 index of less than 1.3 within 10 weeks prior to obtaining consent Patients with fatty liver caused by medication or Wilson's disease (specific aetiology SLD) Patients who fall under the contraindications for pemafibrate (patients with a history of hypersensitivity to the ingredients, patients with severe liver damage, patients with cirrhosis classified as Child-Pugh B or C, patients with biliary obstruction, patients with gallstones, pregnant women or women who may be pregnant, patients receiving cyclosporine or rifampicin) Patients undergoing treatment for malignant diseases, including liver cancer Patients who have received treatment with fibrates or selective PPAR modulators within 12 weeks of obtaining consent Other patients deemed unsuitable as research subjects by the principal investigator or sub-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fibrosis and liver lipid content after 48 weeks of pemafibrate administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood tests, serum fibrosis markers, fatty acid fractionation, and body composition analysis | — |
Countries
Japan
Contacts
Public ContactAkira Uchiyama
Juntendo University School of Medicine Gastroenterology
Outcome results
None listed