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REMBRANDTA 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)

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What is being tested

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

+ Placebo

DrugOther
Who is being recruted

Arterial Occlusive Diseases+13

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 45 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorNewAmsterdam Pharma
Study ContactGlobal Clinical Trial LeadMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 16, 2024

Actual date on which the first participant was enrolled.

This study is focused on adults with atherosclerotic cardiovascular disease (ASCVD) who are at high risk and not seeing enough improvement from their current treatments. The goal is to evaluate if a daily combination of two medications, obicetrapib and ezetimibe, can better manage their condition. This is important because improving the treatment for ASCVD could help reduce the risk of heart-related problems in these patients. By targeting people whose current treatments aren't fully effective, the study aims to find new ways to manage this serious health issue. Participants in the study will take a daily dose of the combined medications, obicetrapib and ezetimibe, in pill form. The study uses a special imaging technique called cardiovascular computed tomography angiography (CCTA) to look at the effects of the medication on the heart's arteries, specifically checking changes in plaque and inflammation. This method allows researchers to see how well the treatment is working in a precise and detailed way. There is a control group that receives a placebo, a substance with no active medication, to compare results and ensure that any changes are due to the treatment itself.

Official TitleA 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)
NCT06305559
Principal SponsorNewAmsterdam Pharma
Study ContactGlobal Clinical Trial LeadMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesHyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaPathological Conditions, AnatomicalDyslipidemiasLipid Metabolism DisordersPlaque, Atherosclerotic

Criteria

5 inclusion criteria required to participate
Fasting serum LDL-C ≥70 mg/dL (≥1.81 mmol/L)
Evaluable non-calcified plaque of at least 75 mm3 in the major epicardial coronary arteries
BMI 18-40, inclusive
Max tolerated lipid modifying therapy
Show More Criteria
4 exclusion criteria prevent from participating
HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
Contraindications for CCTA
History of coronary artery bypass graft
Active liver disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Group II

Placebo
Placebo on top of baseline lipid modifying therapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

NGMR

Hialeah, United StatesOpen NGMR in Google Maps
Recruiting
One Study Center