Evaluating the effect of obicetrapib and ezetimibe on coronary plaque in high-risk patients
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)
This study is testing if a daily combination of obicetrapib and ezetimibe can reduce coronary plaque and inflammation in adults with high-risk heart disease who aren't getting enough help from their current cholesterol medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | NewAmsterdam Pharma Industry-sponsored |
| Locations | 1 site (Hialeah, Florida) |
| Trial ID | NCT06305559 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial is a placebo-controlled, double-blind, randomized study aimed at adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximum tolerated lipid-modifying therapy. The study evaluates the impact of a fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg taken daily on coronary plaque and inflammation characteristics. The assessment will be conducted using cardiovascular computed tomography angiography (CCTA) to measure changes in coronary plaque volume and inflammation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with high-risk atherosclerotic cardiovascular disease who have LDL levels greater than 70 mg/dL and total coronary plaque volume exceeding 75 mm3.
Not a fit: Patients with poorly controlled diabetes (HbA1c >10), contraindications for CCTA, or a history of coronary artery bypass graft may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of coronary artery disease by effectively reducing coronary plaque in high-risk patients.
How similar studies have performed: Other studies have shown promise in using lipid-modifying therapies to reduce coronary plaque, making this approach a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * LDL \>70md/dL * Total coronary plaque \> 75mm3 * BMI 18-40 * Max tolerated lipid modifying therapy * eGFR greater/equal to 40 Exclusion Criteria: - HbA1c \>10 * Contraindications for CCTA * History of coronary artery bypass graft * Active liver disease
Where this trial is running
Hialeah, Florida
- Ngmr — Hialeah, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Global Clinical Trial Lead
- Email: shayleen.vanvuuren@fortrea.com
- Phone: +27 82 495 9889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.