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)
NewAmsterdam Pharma
300 participants
May 16, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria4
- 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
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Interventions
Active treatment
Baseline lipid modifying therapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06305559