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Anti-inflammatory Effects of Extended-Release Pemafibrate

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056031
Enrollment
50
Registered
2024-11-15
Start date
2024-06-18
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

Dyslipidemia

Interventions

None listed

Sponsors

University of Occupational and Environmental Health, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects include cases of dyslipidemia among patients who have visited the outpatient clinic or been admitted to the Second Department of Internal Medicine at the University of Occupational and Environmental Health Hospital. The study considers patients for whom treatment with pemafibrate XR is being evaluated, including those changing from other medications.

Exclusion criteria

Exclusion criteria: Patients who did not provide consent to participate in this study Patients with a history of hypersensitivity to any component of this drug Patients with severe hepatic impairment, cirrhosis classified as Child-Pugh B or C, or biliary obstruction Patients with gallstones Pregnant women or women who may be pregnant Patients currently receiving cyclosporine or rifampicin Any other patients deemed unsuitable for participation by the attending physician

Design outcomes

Primary

MeasureTime frame
Change in inflammatory markers from baseline at 24 weeks

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactJun-ichiro Koga

University of Occupational and Environmental Health, Japan The Second Department of Internal Medicine

j-koga@med.uoeh-u.ac.jp0936917436

Outcome results

None listed

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