A single-arm study of the efficacy of pemafibrate in patients with NAFLD (non-alcoholic fatty liver disease) complicated by dyslipidemia

Clinical Study on Efficacy of Pemafibrate in NAFLD (Non-Alcoholic Fatty Liver Disease) Patients with Dyslipidemia - SPND study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049937

Enrollment

Registered

2023-01-10

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD (non-alcoholic fatty liver disease) complicated by dyslipidemia

Interventions

Pemafibrate 0.1 mg twice daily was administered for 48 weeks, and the patients were evaluated every 12 weeks by examination and blood test. Fibro-scans were performed before and 48 weeks after pemafi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: NAFLD patients with Dyslipidemia diagnosed by (1) the presence of steatosis in 5% or more of hepatocytes on liver biopsy specimens or fat deposition on ultrasonography; (2) daily alcohol consumption of less than 30g for men and less than 20g for women; and (3) absence of other chronic liver diseases, such as viral hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, Wilson's disease, and hemochromatosis, as determined by specific laboratory and imaging examinations, as well as the patients' medical histories. Determination of dyslipidemia was defined as serum triglycerides 150 mg/dL or more, low-density lipoprotein (LDL) cholesterol 140 mg/dL or more, or high-density lipoprotein (HDL) cholesterol less than 40 mg/dL or having been treated for dyslipidemia.

Exclusion criteria

Exclusion criteria: The main exclusion criteria were as follows: (1) age <20??ears; (2) new administration of vitamin E, pioglitazone, SGLT2-Is, and GLP-1 RA known to be potentially effective for NAFLD and other antilipidemic agents within 12??eeks prior to pemafibrate treatment; (3) decompensated cirrhosis; and (4) pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
AST, ALT, gamma-GTP, ALP, albumin, type4 collagen-7S domain, FIB-4 index, NFS, LSM, CAP after 48 weeks of pemafibrate treatment	—

Secondary

Measure	Time frame
triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol, HOMA-IR after 48 weeks of pemafibrate administration	—

Countries

Japan

Contacts

Public ContactHroki Ono

Nippon Medical School Tamanagayama Hospital gastroenterology

h-ono0@nms.ac.jp042-371-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026