Effect of pemafibrate on liver fibrosis in MetALD with hypertriglyceridemia (PELMET)

UMIN ID: UMIN000056083

Registered date:10/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: MetALD complicated with dyslipidemia
• Date of first enrollment: 2024/11/10
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 fibrosis (MRE, MRI-T1 mapping, MR fingerprinting, FibroScan), evaluation of liver inflammation (MRI-T1/T2 mapping, MR fingerprinting), measurement of liver lipid content (MRI-PDFF, MR fingerprinting, FibroScan)

Outcome(s)

• Primary Outcome: Liver fibrosis and liver lipid content after 48 weeks of pemafibrate administration.
• Secondary Outcome: Blood tests, serum fibrosis markers, fatty acid fractionation, and body composition analysis

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Juntendo University School of Medicine
• Source(s) of Monetary Support: Kowa company