Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Prior treatment

• Treatment with investigational product
• Treatment with gemfibrozil or ezetimibe
• Previous participation in a trial evaluating obicetrapib

Other illness

• Hospitalized for heart failure within the last 5 years
• Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
• Uncontrolled severe hypertension
• Liver disease
• History of malignancy
• Known allergy to study drugs, placebo or excipients in study drugs of placebo
• Other condition that would interfere with the conduct of the study

Lab values

• History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction \<30%
• HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
• Thyroid-stimulating hormone \>1.5 x upper limit of normal (ULN)
• Creatinine kinase (CK) \>3 X ULN

Other

• Diagnosis of homozygous FH
• Alcohol abuse

• Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
• On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
• LDL-C ≥ 70 mg/dL
• Triglycerides \< 500
• Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2