Evidence mapPaperPMID 39158261Full record

ArticleJournal of clinical pharmacology2024

A Randomized, Parallel, Open-Label, Single-Dose and Multiple-Dose Clinical Trial to Investigate the Pharmacokinetic, Pharmacodynamic, and Safety Profiles of Obicetrapib in Healthy Participants in China.

Jing Zhang, Guoying Cao, Yong Huo, Liana L Guarneri, Marc Ditmarsch, John J P Kastelein, Douglas Kling, Andrew Hsieh, Erin Wuerdeman, Michael H Davidson

Abstract read
In one paragraph

Article in Journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

10 authors.

Jing ZhangClinical Pharmacology Research Center, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
Guoying CaoClinical Pharmacology Research Center, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
Yong HuoDepartment of Pharmacy, Peking University First Hospital, Beijing, China.
Liana L GuarneriMidwest Biomedical Research, Addison, IL, USA.
Marc DitmarschNewAmsterdam Pharma, Naarden, The Netherlands.
John J P KasteleinNewAmsterdam Pharma, Naarden, The Netherlands.
Douglas KlingNewAmsterdam Pharma, Naarden, The Netherlands.
Andrew HsiehNewAmsterdam Pharma, Naarden, The Netherlands.
Erin WuerdemanNewAmsterdam Pharma, Naarden, The Netherlands.
Michael H DavidsonNewAmsterdam Pharma, Naarden, The Netherlands.

Funding

NewAmsterdam Pharma, Naarden, The Netherlands
6 · The paper itself

Abstract

Obicetrapib is a selective cholesteryl ester transfer protein (CETP) inhibitor. Previous research has demonstrated similar pharmacokinetic (PK) responses to single doses of obicetrapib between Japanese and White males, but the PK responses have not been established in Chinese individuals. The purpose of this randomized, parallel, open-label trial was to characterize the PK and pharmacodynamic (PD; CETP activity and plasma lipids) responses and safety of single doses (5, 10, or 25 mg; N = 36) and multiple doses (10 mg for 14 days; N = 12) of obicetrapib in healthy Chinese individuals. The maximum concentration and area under the drug concentration-time curve of obicetrapib from 0 h to infinity increased with dose after all single doses of obicetrapib. After 7 consecutive days of dosing, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol reached their minimum and maximum changes of 42% reduction and 108% increase, respectively. Primary PK and PD parameters after single- and multiple-dose administration of obicetrapib were similar to those in healthy white participants in previous studies. One participant in the 5 mg dose group experienced a treatment-emergent adverse event of decreased white blood cell and neutrophil counts, which resolved without intervention. In conclusion, these findings support the inclusion of Chinese individuals in the ongoing phase 3 clinical development program of obicetrapib.

Indexed as

Chinesecholesteryl ester transfer proteinclinical trialsdyslipidemiaobicetrapib

Identifiers

PMID39158261
PMCPMC11683177

What Socratic holds

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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 Socratic graph.