臨床研究等提出・公開システム

Date of registration	May. 07, 2026
Last modified on	May. 07, 2026
Trial ID	jRCT1071260020

Scientific Title	Exploratory Study on the Anti-inflammatory Effects of Extended-Release Pemafibrate in Patients with Dyslipidemia
Public Title	Anti-inflammatory Effects of Extended-Release Pemafibrate

Contact for Scientific Queries	Name	Koga Jun-ichiro
	Affiliation	University of Occupational and Environmental Health, Japan
	Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
	Telephone	+81-93-691-7436
	E-mail	j-koga@med.uoeh-u.ac.jp
Contact for Public Queries	Name	Koga Jun-ichiro
	Affiliation	University of Occupational and Environmental Health, Japan
	Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan
	Telephone	+81-93-691-7436
	E-mail	j-koga@med.uoeh-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 07, 2026
Actual date of first enrollment		June. 28, 2024
Target sample size		50
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Outpatient patients or patients hospitalized at the Second Department of Internal Medicine, University of Occupational and Environmental Health, Japan, where the extended-release pemafibrate for dyslipidemia is prescribed (including switching from other medications). Patients without a prescription of pemafibrate are enrolled as controls.
	Exclusion Criteria	Patients meeting any of the following criteria will be excluded from the study: - Patients who have not consented to participate in the study - Patients with a history of hypersensitivity to any component of the study drug - Patients with severe liver dysfunction, Child-Pugh class B or C liver cirrhosis, or biliary obstruction - Patients with cholecystolithiasis - Pregnant women or women who may be pregnant - Patients currently receiving cyclosporine or rifampicin - Other patients deemed inappropriate for participation by the physician
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dyslipidemia
Primary Outcome(s)		Change in inflammatory markers from baseline at 24 weeks
Secondary Outcome(s)		Change in leukocyte count and differential count of leukocytes from baseline at 12 and 24 weeks Change in liver and kidney function from baseline at 12 and 24 weeks Change in serum lipids from baseline at 12 and 24 weeks Change in other blood test parameters from baseline at 12 and 24 weeks Change in oxidative stress markers from baseline at 24 weeks Occurrence of cardiovascular events through the study period

Primary Sponsor	None, Self-Directed Research

Secondary Sponsor

Source of Monetary Support	Japan Society for the Promotion of Science (JSPS)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Institutional Review Board of University of Occupational and Environmental Health, Japan
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan, Fukuoka
Telephone	+81-93-691-7127
E-Mail	rinshokenkyu@mbox.clnc.uoeh-u.ac.jp
Approval Status	Approval
Date of approval	June. 18, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None