Evidence map›Paper›PMID 39098034›Full record

Trial reportJournal of atherosclerosis and thrombosis2025

Efficacy and Safety of Pemafibrate, a Novel Selective PPARα Modulator in Chinese Patients with Dyslipidemia: A Double-Masked, Randomized, Placebo- and Active-Controlled Comparison Trial.

Wenli Dai, Qiang Lv, Qingling Li, Lu Fu, Yawei Zhang, Yumin Zhang, Lijun Liu, Ryohei Tanigawa, Keisuke Kunitomi, Ryo Kamei and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of atherosclerosis and thrombosis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04998981 (A Phase 3, Multi-Center, Placebo- and Active-Controlled, Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04998981 phase3completednot on this map

A Phase 3, Multi-Center, Placebo- and Active-Controlled, Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

TypeinterventionalSponsorKowa Company, Ltd.Ran2021 to 2023Enrolled353ConditionsHyperlipidemiaArmsK-877 0.1 mg tablet, Fenofibrate 200 mg capsule, Placebo tablet, Placebo capsule
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Journal of clinical and experimental hepatology
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Wenli DaiBeijing Anzhen Hospital, Capital Medical University.
Qiang LvBeijing Anzhen Hospital, Capital Medical University.
Qingling LiChengdu Xinhua Hospital.
Lu FuThe First Affiliated Hospital of Harbin Medical University.
Yawei ZhangPingxiang People's Hospital.
Yumin ZhangThe Third Hospital of Changsha.
Lijun LiuThe First Hospital of Anhui University of Science and Technology.
Ryohei TanigawaClinical Development Department, Kowa Company, Ltd.
Keisuke KunitomiClinical Development Department, Kowa Company, Ltd.
Ryo KameiMedical Affairs Department, Kowa Company, Ltd.
Hideki SuganamiData Science Center, Kowa Company, Ltd.
Changsheng MaBeijing Anzhen Hospital, Capital Medical University.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsPemafibrate substantially lowers serum triglyceride (TG) levels and increases high-density lipoprotein cholesterol (HDL-C) levels primarily in Japan, but it has not been evaluated in China. We aimed to confirm the efficacy and safety of pemafibrate in Chinese patients with hypertriglyceridemia and low HDL-C levels by comparing placebo and fenofibrate.

methodsA multicenter, double-masked trial was conducted in China involving 344 patients with high TG and low HDL-C levels randomly assigned to one of four groups: pemafibrate 0.2 mg/d, pemafibrate 0.4 mg/d, fenofibrate 200 mg/d, or placebo for 12 weeks. The primary endpoint was the percentage change in fasting TG levels.

resultsThe percentage change in TG levels from baseline was -34.1%, -44.0%, -30.5%, and 6.5% in the pemafibrate 0.2 mg/d, pemafibrate 0.4 mg/d, fenofibrate 200 mg/d, and placebo groups, respectively. Pemafibrate 0.4 mg/d significantly reduced TG levels compared with that in both placebo (p＜0.0001) and fenofibrate groups (p=0.0083). Significant improvements in HDL-C, remnant cholesterol, and apolipoprotein A1 levels were also observed with both doses of pemafibrate than with the placebo. Pemafibrate showed significantly smaller changes in alanine aminotransferase, aspartate aminotransferase, and serum creatinine levels than those with fenofibrate.

conclusionsIn Chinese patients, pemafibrate exhibited superior efficacy in improving TG levels and enhanced hepatic and renal safety compared to fenofibrate. Thus, pemafibrate may represent a promising therapeutic option for dyslipidemia in Chinese patients.

Indexed as

BenzoxazolesButyratesDyslipidemiasHypolipidemic AgentsPPAR alphaAdultAgedChinaCholesterol, HDLDouble-Blind MethodEast Asian PeopleFemaleFenofibrateFollow-Up StudiesHumansMaleBenzoxazolesButyratesCholesterol, HDLFenofibrateHypolipidemic AgentsPPAR alphaPPARA protein, human(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acidTriglyceridesClinical trialDyslipidemiaPemafibrateSelective PPARα modulatorTriglyceride

Identifiers

PMID39098034
PMCPMC11802246

What Socratic holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.