A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque (REMBRANDT)

• Research type

  Research Study

• Full title

  A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib/Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants with Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT trial)

• IRAS ID

  1009834

• Contact name

  Annie Neild

• Contact email

  annie.neild@newamsterdampharma.com

• Sponsor organisation

  NewAmsterdam Pharma B.V.

• Clinicaltrials.gov Identifier

  NCT06305559

• Research summary

  The purpose of this study is to compare the effects of obicetrapib on coronary plaque characteristics and the levels of low-density lipoprotein cholesterol (LDL-C) in the blood when administered together with ezetimibe as a fixed-dose combination (FDC) to those seen in participants receiving placebo. The study will also check how safe the FDC of obicetrapib and ezetimibe is for participants with high levels of LDL-C in the blood.

  Obicetrapib is designed to help lower the LDL-C levels in addition to diet and cholesterol-lowering therapy. Obicetrapib is an experimental drug which is not approved by Health Authorities including MHRA for the treatment of high levels of LDL-C in the blood. Ezetimibe, known to inhibit cholesterol absorption in the intestine, is approved as a treatment for high levels of LDL-C in the blood by the U.S. Food and Drug Administration (FDA) and/or Health Authorities in United Kingdom. But FDC of obicetrapib and ezetimibe is considered an experimental drug because it has not been approved by the FDA or any other health authority.

  Approximately 300 people will take part in this study at several different locations globally.

  The study consists of a Screening period (up to 42 days), Treatment period (about 545 days or 18 months), and Safety Follow-up visit (35 days after last dose of the study drug). This study will have 7 study visits over a period of 622 days.

  This study is randomized and double-blind.
  Participants who qualify for this study will be randomly (like the flip of a coin) assigned by a computer to get one of the following treatment groups:
  • Obicetrapib 10 mg + ezetimibe 10 mg FDC tablet once daily
  • Placebo tablet once daily

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  24/LO/0323

• Date of REC Opinion

  25 Jun 2024

• REC opinion

  Further Information Favourable Opinion