Overview
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 Criteria:
- 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 Criteria:
- 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
