Metabolic dysfunction associated steatotic liver disease
Conditions
Interventions
None listed
Sponsors
Asahikawa Medical University
Nayoro City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with hypertriglyceridemia (fasting TG>=150 mg/dL or non-fasting TG>=175 mg/dL). 2) Patients who started to use pemafibrate, and who give their consent to participate in this study within 8 weeks after the start of prescription of it. 3) Patient has been diagnosed with steatotic liver disease by imaging examination. 4) Patients with Chronic hepatitis (ALT>30IU/L). 5) Patients whose ages are between 18 and 80 years old at the time of obtaining consent.
Exclusion criteria
Exclusion criteria: 1)Patients who are prohibited to use pemafibrate Patients with known hypersensitivity to pemafibrate or to any of the excipients Patients with severe hepatic disorder, Child-Pugh grade B or C cirrhosis, or biliary obstruction Patients with cholelithiasis Pregnant or possibly pregnant women Patients receiving concomitant cyclosporine or rifampicin 2)Patients with chronic liver disease other than MASLD Drug-induced liver injury Autoimmune hepatitis Primary biliary cholangitis Primary sclerosing cholangitis 3)Patients whose daily drinking amount is more than 30 g per day for men and more than 20 g for women in terms of ethanol 4) Patients who have started using the following drugs or changed their dosage within 12 weeks prior to obtaining consent Pioglitazone, GLP-1 receptor agonists, SGLT2 inhibitors, GIP/GLP-1 receptor agonists HMG-CoA reductase inhibitors (statins) Other fibrates ARBs, ACE inhibitors Vitamin E 5) Patients with other conditions that the investigators judge to be inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SWD from baseline to 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SWD from baseline to 24 weeks. Change in imaging examination, fibrosis markers from baseline to 24 and 48 weeks. Change in physical examination, blood tests from baseline to 12, 24, 36 and 48 weeks. Change in ferritin, liver/spleen CT ratio (L/S ratio), visceral fat area, muscle mass at the L3 level, grip strength, lean mass, body fat mass, muscle mass, skeletal muscle mass, skeletal muscle index, and liver tissue score from baseline to 48 weeks. Relationship between various indices. Incidence of adverse events and adverse drug reactions. | — |
Countries
Japan
Contacts
Public ContactShunsuke Nakajima
Asahikawa Medical University Department of Emergency Medicine
Outcome results
None listed