Effects of pemafibrate on liver inflammation and fibrosis in patients with metabolic dysfunction associated steatotic liver disease complicated by hypertriglyceridemia: A multi-center prospective observational study

UMIN ID: UMIN000055404

Registered date:03/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Metabolic dysfunction associated steatotic liver disease
• Date of first enrollment: 2024/09/03
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in SWD from baseline to 48 weeks
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Asahikawa Medical University
• Secondary Sponsor: Nayoro City General Hospital
• Source(s) of Monetary Support: Kowa company, Ltd.