Evidence map›Paper›PMID 40569335›Full record

ArticleAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2025

A Drug-Drug Interaction Study Evaluating the Pharmacokinetic Consequences of Obicetrapib Therapy on Atorvastatin or Rosuvastatin Levels in Healthy Volunteers.

John J P Kastelein, Marc Ditmarsch, Andrew Hsieh, Douglas Kling, Ashley Walker, Mary R Dicklin, Zia Tayab, Mohammed Bouhajib, Michael H Davidson

Registry-linked trialAbstract read
In one paragraph

Article in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06081166 (A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06081166 phase1completednot on this map

A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects

TypeinterventionalSponsorNewAmsterdam PharmaRan2023 to 2024Enrolled74ConditionsHealthy VolunteersArmsObicetrapib, Atorvastatin Calcium, Rosuvastatin Calcium
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. CETP Renaissance with Obicetrapib.Current atherosclerosis reports · 2026
    Review
  2. 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

9 authors.

John J P KasteleinNewAmsterdam Pharma B.V., Gooimeer 2-35, 1411 DC, Naarden, The Netherlands.
Marc DitmarschNewAmsterdam Pharma B.V., Gooimeer 2-35, 1411 DC, Naarden, The Netherlands.
Andrew HsiehNewAmsterdam Pharma B.V., Gooimeer 2-35, 1411 DC, Naarden, The Netherlands. Andrew.Hsieh@newamsterdampharma.com.
Douglas KlingNewAmsterdam Pharma B.V., Gooimeer 2-35, 1411 DC, Naarden, The Netherlands.
Ashley WalkerNewAmsterdam Pharma B.V., Gooimeer 2-35, 1411 DC, Naarden, The Netherlands.
Mary R DicklinMidwest Biomedical Research, Addison, IL, USA.
Zia TayabPharma Medica Research Inc., Mississauga, ON, Canada.
Mohammed BouhajibPharma Medica Research Inc., Mississauga, ON, Canada.
Michael H DavidsonNewAmsterdam Pharma B.V., Gooimeer 2-35, 1411 DC, Naarden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveObicetrapib, a selective cholesteryl ester transfer protein inhibitor in development for the treatment of dyslipidemia and cardiovascular risk, is expected to be administered with high-intensity statins in clinical practice. This study was performed to assess the effect of obicetrapib on the pharmacokinetics (PK) of atorvastatin and rosuvastatin.

methodsAn open-label study was conducted to evaluate the PK of atorvastatin 80 mg (cohort 1, n = 42) or rosuvastatin 40 mg (cohort 2, n = 32, non-Asians) with and without co-administration of 10 mg obicetrapib in healthy adult males and females. Study participants received statin on day - 4, obicetrapib on days 1-11, statin co-administered with obicetrapib on day 12, and obicetrapib on days 13-17. Blood samples were collected throughout the dosing period and analyzed for plasma obicetrapib (both cohorts); atorvastatin, ortho-hydroxy atorvastatin, and para-hydroxy atorvastatin (cohort 1), and rosuvastatin (cohort 2). Safety and tolerability were also assessed.

resultsThe 90% confidence intervals of the geometric mean ratios for the log-transformed maximum plasma concentration and area under the curve from time 0 to the time of the last measurable concentration (AUC

conclusionsNo clinically significant PK interaction occurred between multiple daily doses of obicetrapib on the single-dose PK of either atorvastatin or rosuvastatin in healthy volunteers. CLINICAL

trial registrationNCT06081166.

Indexed as

AtorvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumAdultArea Under CurveCholesterol Ester Transfer ProteinsCohort StudiesDrug InteractionsFemaleHealthy VolunteersHumansMaleMiddle AgedYoung AdultAtorvastatinCholesterol Ester Transfer ProteinsHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin Calcium

Identifiers

PMID40569335
PMCPMC12378308

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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 OpenQuestion graph.