Evidence map›Paper›PMID 41320340›Full record

Trial reportJournal of atherosclerosis and thrombosis2026

Long-term Safety and Efficacy of Bempedoic Acid in Japanese Patients with Hypercholesterolemia: the CLEAR-J LONG.

Daisaku Masuda, Kouji Kajinami, Nobutaka Sakayoshi, Daisuke Yokota, Masakazu Nagamine, Yuki Morikawa-Isogai, Shizuya Yamashita

Abstract readMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Journal of atherosclerosis and thrombosis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

7 authors.

Daisaku MasudaDepartment of Cardiology, Rinku General Medical Center.
Kouji KajinamiDepartment of Cardiology, Kanazawa Medical University.
Nobutaka SakayoshiHeadquarters of Clinical Development, Otsuka Pharmaceutical Co. Ltd.
Daisuke YokotaHeadquarters of Clinical Development, Otsuka Pharmaceutical Co. Ltd.
Masakazu NagamineMedical Affairs, Otsuka Pharmaceutical Co., Ltd.
Yuki Morikawa-IsogaiMedical Affairs, Otsuka Pharmaceutical Co., Ltd.
Shizuya YamashitaDepartment of Cardiology, Rinku General Medical Center.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsBempedoic acid is an ATP citrate lyase (ACLY) inhibitor acting in the cholesterol biosynthesis pathway. This study evaluated long-term safety and efficacy of bempedoic acid 180 mg/day for 52 weeks in Japanese patients with hypercholesterolemia.

methodsA multicenter, open-label, single-arm Phase 3 long-term study was conducted at 26 hospitals and clinics across Japan in patients aged 18 to 85 years. Newly enrolled patients had previously failed to achieve their lipid management targets because of inadequate response to statins or statin intolerance; rollover patients had completed the 12-week treatment period of a domestic Phase 3 confirmatory study (the CLEAR-J trial) and had not met the discontinuation criteria at Week 12.

resultsBempedoic acid was administered to 130 patients. Treatment-emergent adverse events (TEAEs) occurred in 83.8%, treatment-related TEAEs in 14.6%, serious TEAEs in 6.2%, and AEs leading to discontinuation in 4.6%. None were severe. Between baseline and Week 52, low-density lipoprotein-cholesterol (LDL-C) decreased by 21.6% (overall population) and 25.3% (newly enrolled group), as observed in both statin response subgroups. LDL-C target levels based on risk category were achieved by 65.6% at Week 52 (overall population). Long-term efficacy was also demonstrated for non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein.

conclusionsBempedoic acid 180 mg/day for 52 weeks was well tolerated in patients with hypercholesterolemia, with no major safety concerns. Serious AEs were infrequent, and no new safety signals specific to the Japanese population were observed. More than 60% of patients achieved and sustained their LDL-C target levels.

Indexed as

Anticholesteremic AgentsDicarboxylic AcidsFatty AcidsHypercholesterolemiaAdolescentAdultAgedAged, 80 and overCholesterol, LDLEast Asian PeopleFemaleFollow-Up StudiesHumansJapanMaleMiddle Aged8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidAnticholesteremic AgentsCholesterol, LDLDicarboxylic AcidsFatty AcidsBempedoic acidHypercholesterolemiaInadequate response to statinsLong-term safetyStatin intolerance

Identifiers

PMID41320340
PMCPMC13053208

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Registered trials

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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 OpenQuestion graph.