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Peer-Reviewed Publication
Am Heart J2025;290325-338.December 1, 2025Journal Article

Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics.

Cian P McCarthy1, Christie M Ballantyne2, Ron Blankstein3, Matthew J Budoff4, Marc Ditmarsch5, C Michael Gibson6, John J P Kastelein7, Ann Marie Navar8, Stephen J Nicholls9, Kausik K Ray10, Cheerag Shirodaria11, Michelle C Williams12, James L Januzzi13
1Heart and Vascular Institute, Mass General Brigham, Boston, MA; Baim Institute for Clinical Research, Boston, MA.
2Section of Cardiovascular Research and Center for Cardiometabolic Disease Prevention, Department of Medicine, Baylor College of Medicine, Houston, TX.
3Heart and Vascular Institute, Mass General Brigham, Boston, MA.
4Lundquist Institute, Torrance, CA.
5NewAmsterdam Pharma, Naarden, The Netherlands.
6Baim Institute for Clinical Research, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
7NewAmsterdam Pharma, Naarden, The Netherlands; Department of Vascular Medicine, University of Amsterdam, The Netherlands.
8Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.
9Baim Institute for Clinical Research, Boston, MA; Victorian Heart Institute, Monash University, Melbourne, Australia.
10Baim Institute for Clinical Research, Boston, MA; Department of Public Health and Primary Care, Imperial College, London, UK.
11Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Caristo Diagnostics, Oxford, UK.
12British Heart Foundation Centre for Research Excellence, University of Edinburgh, Edinburgh, UK.
13Heart and Vascular Institute, Mass General Brigham, Boston, MA; Baim Institute for Clinical Research, Boston, MA. Electronic address: jjanuzzi@mgb.org.

Abstract

BACKGROUND: Obicetrapib is a potent, selective cholesteryl ester transfer protein (CETP) inhibitor that significantly lowers low-density lipoprotein cholesterol (LDL-C). Additive reductions in LDL-C occur when obicetrapib is combined with ezetimibe. The impact of obicetrapib and ezetimibe fixed-dose combination (FDC) on coronary plaque burden is unknown. Favorable changes in noncalcified coronary…

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