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更新于：2026-02-26
Kowa Co., Ltd.
更新于：2026-02-26
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NCT06525311
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis
NCT06247735
A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study With a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment
JPRN-jRCT1061230070
The effects Of sodium-glucose coTransporter 2 inhibiTOR on fastIng Hepatic Insulin Clearance in type 2 diabetes - TOTTORI-HIC study
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2026-04-01AMERICAN HEART JOURNAL
A multicenter trial to test pitavastatin calcium in youth with combined dyslipidemia of obesity: Design, implementation, challenges, and responses
Article
作者: Cartoski, Mark J ; de Ferranti, Sarah D ; Arslanian, Silva A ; Raghuveer, Geetha ; Sponseller, Craig A ; Shah, Amy S ; Freemon, D'Andrea R ; Mietus-Snyder, Michele ; Atz, Andrew M ; Peterson, Amy ; Ware, Adam L ; McCrindle, Brian W ; Zadokar, Varsha V ; Brothers, Julie A ; Teng, Jessica E ; Trachtenberg, Felicia L ; Stylianou, Mario ; Russell, Mark W ; Magge, Sheela N ; Urbina, Elaine M ; Mahle, William T ; Zachariah, Justin
BACKGROUND:
Combined dyslipidemia of obesity (CDO) is a prevalent atherogenic lipid disorder characterized by high TG, low HDL, high non-HDL, and a preponderance of small LDL particles. Lifestyle modification is the mainstay of treatment but is often insufficient; a pharmacologic approach could augment care but has not been rigorously evaluated.
METHODS:
The dyslipidemia of obesity intervention in teens (DO IT!) Trial was a 2-year randomized controlled double-blind study designed to measure the effect and safety profile of pitavastatin calcium vs placebo on vascular measures of early atherosclerosis, and standard and advanced lipid profiles in children and adolescents with CDO. We present the rationale, design, and study procedures, and share challenges, responses, and lessons learned.
RESULTS:
Participants were recruited from 17 sites; goal 177, with 122 consented (68.9%). Facilitators to recruitment included familiarity of site investigators with CDO management, relationship with local obesity programs, and study incentives. Barriers included 2-year study duration, number of study visits, and COVID-19 pandemic effects. The research team added recruitment sites, expanded eligibility, shared educational and promotional materials, and bolstered site engagement but enrollment was insufficient, and the trial was stopped early.
CONCLUSIONS:
The DO IT! Trial was the first to evaluate effects of pitavastatin vs placebo on vascular measures, lipid outcomes and potential adverse effects. Recruitment challenges limited the study sample, but findings may still inform cardiovascular prevention. Future studies are more likely to be more successful with early patient-family input, shorter study duration, and fewer study visits integrated with clinical care close to home.
CLINICALTRIALS:
gov identifier: NCT02956590.
2026-01-01Drug information journal
Risk of Venous Thromboembolism with Pemafibrate in Dyslipidemia: A Nationwide, Retrospective, Cohort Study Using a Japanese Claims Database
Article
作者: Kasano, Atsushi ; Suganami, Hideki ; Tada, Mika ; Watanabe, Yoshinari ; Minamikawa, Sara ; Nakano, Shun ; Ikeda, Kenichiro ; Yokoyama, Kenji ; Tsushio, Takuma ; Ishiguro, Chieko ; Tanahashi, Masaya ; Fujisawa, Kenji
Abstract:
Aims:
The study aimed to assess whether pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, increases the risk of venous thromboembolism (VTE) in real-world clinical practice in Japan.
Methods:
In this retrospective cohort study, we utilized a claims database with data from December 2017 to July 2023. The exposed group consisted of patients with dyslipidemia using pemafibrate, while the control group included patients not using fibrate drugs. Each exposed patient was randomly matched with five control patients at a 1:5 ratio using time-matching. The primary endpoint was the number of days until the first occurrence of VTE, which was defined using ICD-10 codes and anticoagulant prescription records. We used a Cox proportional hazards model with standardized mortality ratio weight (SMRW) to estimate the adjusted hazard ratio (HR) and 95% confidence interval (CI) for the exposed group relative to the control group.
Results:
The study included 23,195 patients in the exposed group and 115,975 in the control group. In the full analysis population, 46.6% of patients were women, with a median age of 70.0 years and a median BMI of 23.6. VTE occurred in 1.2% (286/23,195) of the exposed group and 2.0% (2297/115,975) of the control group, with an incidence rate of 0.95 and 1.33 per 100 person-years, respectively. There was no significant increase in the risk of VTE in the exposed group (HR, 0.925; 95%CI, 0.809–1.058).
Conclusions:
We found no increase in VTE risk associated with pemafibrate in clinical practice in Japan.
2025-11-01Journal of Atherosclerosis and Thrombosis
Effects of Pemafibrate on Cholesterol Synthesis and Absorption: a Post-Hoc Subgroup Analysis of a Phase 2 Clinical Trial
Article
作者: Minamikawa, Sara ; Ishibashi, Shun ; Arai, Hidenori ; Saito, Ayumi ; Araki, Eiichi ; Suganami, Hideki ; Tanigawa, Ryohei ; Yokote, Koutaro ; Yamashita, Shizuya
AIM:
Recently, we reported that a pemafibrate extended-release (XR) formulation lowered low-density lipoprotein cholesterol (LDL-C) and cholesterol synthesis and absorption markers in a phase 2 clinical pharmacology study. Here we describe our post-hoc analysis of that study, discuss the mechanism by which pemafibrate lowers LDL-C, and suggest which patients may respond favorably to pemafibrate treatment.
METHODS:
In the phase 2 study, patients with hypertriglyceridemia received treatment with pemafibrate immediate-release (IR) 0.2 mg/day or XR 0.4 mg/day or 0.8 mg/day. This post-hoc subgroup analysis examined the percentage change in LDL-C, apolipoprotein B (ApoB), non-HDL-C, and cholesterol synthesis and absorption markers, in subgroups by baseline LDL-C, and then determined the correlation between the percentage change in LDL-C and the percentage change in cholesterol synthesis and absorption markers.
RESULTS:
Our analysis included 60 patients who received two of three formulations of the drug. A total of 78.3% (47/60) were male, 16.7% (10/60) had type 2 diabetes mellitus, and 10% (6/60) received concomitant statins. The percentage of LDL-C lowering was greater in the population with high baseline LDL-C, and similar trends were noted for the ApoB, non-HDL-C, and cholesterol synthesis and absorption markers. The percentage change in LDL-C was positively correlated with the percentage change in lathosterol, β-sitosterol, and campesterol.
CONCLUSIONS:
In patients with hypertriglyceridemia, results suggested that pemafibrate lowered LDL-C by inhibiting cholesterol synthesis in the liver and cholesterol absorption from the intestinal tract. This lowering effect was greater in populations with higher baseline LDL-C.
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