Prospective study of pemafIbrate in patients with NAFLD

JRCT ID: jRCTs061230071

Registered date:02/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nonalcoholic fatty liver disease
• Date of first enrollment: 13/12/2023
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Patients with non-alcoholic fatty liver disease with hypertriglyceridemia and type 2 diabetes mellitus who are receiving treatment including SGLT2 inhibitor administration will be assigned to the study. Subjects assigned to the pemafibrate combination group (combination group) will receive pemafibrate orally at a dose of 0.2 mg per day. This will be administered for 24 consecutive weeks.

Outcome(s)

• Primary Outcome: Percentage of those with normalized ALT (males: ALT <42 U/L, females: ALT <28 U/L) at 24 weeks

Secondary Outcome

1 Percentage of those with normalized ALT (males: ALT <42 U/L, females: ALT <28 U/L) at 12 weeks
2 Amount and Percentage Change in Blood Test Values
3 Percent change in liver hardness (VCTE, MRE)
4 Change in fibrosis marker/index
5 Percent change in liver fat content (CAP, ATI)
6 Percentage change in liver fat percentage (MRI-PDFF)
7 Percent change in weight and BMI
8 Percentage of individuals with normalized ALT at 24 weeks between those taking a single SGLT2 inhibitor and those taking multiple concomitant hypoglycemic medications for the treatment of diabetes, as well as 1-7 ratings and comparisons between the two groups
9 Percentage of individuals with normalized ALT at 24 weeks by pemafibrate dose, as well as 1-7 ratings and comparisons between the two groups
10 Adverse Events and Side Effects

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 18 age old over
2 Regardless of gender
3 Patients with fatty liver on imaging (either US/CT/MRI)
4 Patients diagnosed with type 2 diabetes and controlled to HbA1c < 8.0% with treatment including SGLT2 inhibitors for at least 24 weeks
5 Patients with hyper TG hematosis (fasting TG>150 mg/dL or anytime TG>175 mg/dL and fasting/anytime TG<500 mg/dL)
6 Patients with hepatic dysfunction (male: 42 U/L < ALT < 126 U/L, female: 28 U/L < ALT < 84 U/L)
7 Patienst or proxy who have been fully informed consent

Exclude criteria

1 Patients with complications of other liver diseases such as active viral hepatitis, autoimmune hepatitis, primary cholestatic cholangitis, drug-induced liver injury
2 Alcohol consumption, 30 g/day or more (men) or 20 g/day or more (women) in terms of ethanol
3 Patients taking concomitantly prohibited drugs (see 4.6.2 Concurrently Prohibited Drugs (Therapy))
4 Patients with liver cirrhosis of Child-Pugh Classification B or C
5 Patients with a history of Allergy to pemafibrate
6 Patients with gallstones or biliary obstruction
7 Patients scheduled to receive additional or changed hypoglycemic medications
8 Prior treatment with fibrates or SPPARM within 12 weeks of obtaining consent
9 Being pregnant or possibly pregnant
10 Patients who judged as inappropriate candidate by the chief medical examine

Related Information

• Primary Sponsor: Otsuka Motoyuki
• Source(s) of Monetary Support: Kowa Company, Ltd.