Tokyo, Jan. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060348) titled 'A Study to Observe Changes in Liver Function and Gut Microbiota in Patients with Fatty Liver Disease and High Triglycerides Receiving Pemafibrate' on Jan. 14.

Study Type: Observational

Primary Sponsor: Institute - Ehime University

Condition: Condition - Metabolic Dysfunction Associated Steatotic Liver Disease and Hypertriglyceridemia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate longitudinal changes in liver function-related clinical parameters in patients with MASLD complicated by hypertriglyceridemia who are treated with pemafibrate Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key 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. Key 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. Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 08 Month 28 Day Date of IRB - 2025 Year 09 Month 03 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066175

Disclaimer: Curated by HT Syndication.