Metabolic Dysfunction Associated Steatotic Liver Disease and Hypertriglyceridemia
Conditions
Interventions
None listed
Sponsors
Ehime University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients will be those who are diagnosed with fatty liver based on imaging modalities (abdominal ultrasonography or MRI-PDFF), fulfill the diagnostic criteria for MASLD, have a fasting serum triglyceride level of over 150 mg/dL, and are considered suitable for pemafibrate therapy by their physician due to inadequate response to dietary and exercise interventions. Written informed consent must be obtained prior to study participation.
Exclusion criteria
Exclusion criteria: Patients with contraindications to pemafibrate (e.g., severe hepatic impairment, biliary obstruction, pregnant or breastfeeding women). Patients with liver diseases other than MASLD, such as viral hepatitis, autoimmune liver disease, or drug-induced liver injury. Patients who have used medications that may affect the gut microbiota (e.g., antibiotics, probiotic supplements) within 3 months prior to study enrollment. Patients with poorly controlled diabetes mellitus, defined as HbA1c over 8.0%. Patients with habitual excessive alcohol consumption, defined as over 30 g/day of pure ethanol for men and over 20 g/day for women. Any other patients deemed inappropriate for participation in the study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in serum ALT from baseline (week 0) to week 24 after initiation of pemafibrate | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in gut microbiota composition and diversity Changes in liver function, lipid profiles, and fibrosis markers Imaging parameters (MRI-PDFF, MRE, ultrasound) Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactTaisei Murakami
Ehime University Graduate School of Medicine Department of Gastroenterology and Metabology
Outcome results
None listed