Evidence map›Paper›PMID 38569868›Full record

Trial reportJournal of atherosclerosis and thrombosis2024

Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects: Results from a Randomized Phase 2 Trial.

Mariko Harada-Shiba, Michael H Davdison, Marc Ditmarsch, Andrew Hsieh, Erin Wuerdeman, Douglas Kling, Annie Nield, Mary R Dicklin, Akitaka Nakata, Atsushi Sueyoshi and 2 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Journal of atherosclerosis and thrombosis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 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.

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

19 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Article
  7. Article
  8. Review
  9. Treatment Target Discovery From Vasculo-Protective Phenotypes.Journal of lipid and atherosclerosis · 2026
    Review
  10. Article
  11. Review
  12. Review
  13. Advances in Non-statin Lipid Therapies: A Narrative Review of Evolving Strategies for Cardiovascular Risk Reduction.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
    Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Obicetrapib: There is still Life in the CETP Inhibitor!Journal of atherosclerosis and thrombosis · 2024
    Article
  19. 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.

Mariko Harada-ShibaCardiovascular Center, Osaka Medical and Pharmaceutical University.
Michael H DavdisonNewAmsterdam Pharma B.V.
Marc DitmarschNewAmsterdam Pharma B.V.
Andrew HsiehNewAmsterdam Pharma B.V.
Erin WuerdemanNewAmsterdam Pharma B.V.
Douglas KlingNewAmsterdam Pharma B.V.
Annie NieldNewAmsterdam Pharma B.V.
Mary R DicklinMidwest Biomedical Research.
Akitaka NakataDepartment of Cardiology, Sanai Hospital.
Atsushi SueyoshiDepartment of Diabetes Internal Medicine, Uji-Tokushukai Medical Center.
Satoshi KuroyanagiDepartment of Cardiovascular Surgery, Kishiwada Tokushukai Hospital.
John J P KasteleinNewAmsterdam Pharma B.V.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsObicetrapib is a highly selective cholesteryl ester transfer protein (CETP) inhibitor shown to reduce low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (apoB), when taken as monotherapy and in combination with ezetimibe on a background of statins, in clinical trials predominantly conducted in Northern European/Caucasian participants. We characterized the efficacy, safety, and tolerability of obicetrapib within an Asian-Pacific region population.

methodsThis double-blind, randomized, phase 2 trial examined obicetrapib 2.5, 5, and 10 mg/d, compared with placebo, for 8 weeks as an adjunct to stable statin therapy (atorvastatin 10 or 20 mg/d or rosuvastatin 5 or 10 mg/d) in Japanese men and women who had not achieved 2022 Japan Atherosclerosis Society Guidelines and had LDL-C >70 mg/dL or non-high-density lipoprotein cholesterol (non-HDL-C) >100 mg/dL and triglycerides (TG) <400 mg/dL. Endpoints included LDL-C, non-HDL-C, HDL-C, very low-density lipoprotein cholesterol, apolipoproteins, TG, steady state pharmacokinetics (PK) in obicetrapib arms, safety, and tolerability.

resultsIn the 102 randomized subjects (mean age 64.8 y, 71.6% male), obicetrapib significantly lowered median LDL-C, apoB, and non-HDL-C, and raised HDL-C at all doses; responses in the obicetrapib 10 mg group were -45.8%, -29.7%, -37.0%, and +159%, respectively (all p<0.0001 vs. placebo). The PK profile demonstrated near complete elimination of drug by 4 weeks. Obicetrapib was well tolerated and there were no adverse safety signals.

conclusionsAll doses of obicetrapib taken as an adjunct to stable statin therapy significantly lowered atherogenic lipoprotein lipid parameters, showed near complete elimination of drug by 4 weeks, and were safe and well tolerated in a Japanese population, similar to previous studies of obicetrapib conducted in predominantly Caucasian participants.

Indexed as

Hydroxymethylglutaryl-CoA Reductase InhibitorsAgedAnticholesteremic AgentsCholesterol Ester Transfer ProteinsCholesterol, LDLDouble-Blind MethodDrug Therapy, CombinationEast Asian PeopleFemaleHumansJapanMaleMiddle AgedAnticholesteremic AgentsCETP protein, humanCholesterol Ester Transfer ProteinsCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsCholesteryl ester transfer proteinDyslipidemiaJapaneseObicetrapibStatin

Identifiers

PMID38569868
PMCPMC11456355

What OpenQuestion holds

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Registered trials

None linked

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.