NCT06305559Active, not recruitingPhase 3
A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
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)
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 28 Feb 2024
- Start date
- 16 May 2024
- Primary completion date
- Nov 2027
- Lead sponsor
- NewAmsterdam Pharma
- Diseases
- Coronary artery disease
- NCT number
- NCT06305559
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 16 May 2024 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of coronary artery bypass graft
- Active liver disease
Lab values
- HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
Other
- Contraindications for CCTA
Who the study is looking for
- 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
- Estimated glomerular filtration rate ≥40 mL/min/1.73 m2
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NGMR Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.