Obicetrapib + Ezetimibe for Coronary Artery Disease (REMBRANDT Trial)

Phase 3

Recruiting

Research Sponsored by NewAmsterdam Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

eGFR greater/equal to 40

Max tolerated lipid modifying therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication combination in adults with high-risk cardiovascular disease who are not responding well to their current treatment. The study aims to see how the new medication affects coronary plaque and inflammation using

Who is the study for?

This trial is for adults with high-risk heart-related artery disease who aren't responding well to their current cholesterol-lowering treatments. They should have a certain amount of plaque in their arteries, a body mass index between 18-40, proper kidney function, and LDL cholesterol over 70mg/dL.

What is being tested?

The study tests if taking obicetrapib plus ezetimibe daily can change the characteristics of coronary plaque and inflammation. This is measured using advanced heart scans (CCTA). Participants are randomly chosen to either receive this combination or a placebo without knowing which one they get.

What are the potential side effects?

Potential side effects may include liver enzyme changes, muscle pain or weakness, digestive issues like stomach pain or diarrhea, headache, fatigue, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal or only mildly reduced.

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I am on the highest dose of medication I can tolerate to manage my cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

• To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months.

Secondary study objectives

Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.

Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.

Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo.

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