A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

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 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

Conditions4

Locations1 site

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