Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies

1. Male or female and >=18 years of age at Screening (Visit 1);

2. Have a history of ASCVD, defined by at least 1 of the following conditions:
- Coronary artery disease
- Cerebrovascular disease
- Peripheral arterial disease

3. Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid
lowering diet and other lifestyle modifications, defined as follows:
- A statin at a maximally tolerated stable dose;
- Ezetimibe for at least 8 weeks with or without a maximally
tolerated statin prior to Screening (Visit 1);
- Bempedoic acid for at least 8 weeks in combination with a
maximally tolerated statin prior to Screening (Visit 1);
- A PCSK9-targeted therapy alone or in combination with other
lipidmodifying therapy for at least 4 stable doses prior to Screening (Visit 1);
- At least 70% of the participants enrolled into this study must be
taking HISs. Documentation in the eCRF of the reason why a participant is
unable to take HISs is required. HISs
include the following:
o Atorvastatin 40 and 80 mg; and
o Rosuvastatin 20 and 40 mg

4. Have a fasting serum LDL-C at Screening (Visit 1) as follows:
- Have a fasting serum LDL-C >=70 mg/dL to <100 mg/dL with at least 1
of the following risk enhancers:
- Recent MI (>3 and <12 months prior to Randomization);
- Type 2 diabetes mellitus;
- Fasting triglycerides (TG) >150 mg/dL (>1.7 mmol/L); and/or
- Fasting high density lipoprotein cholesterol <40 mg/dL (<1.0
mmol/L). OR
- Have a fasting serum LDL-C >=100 mg/dL.

5. Have fasting TG <400 mg/dL (<4.52 mmol/L) at Screening (Visit 1); and

6. Have an estimated glomerular filtration rate (eGFR) >=30 mL/min/1.73 m2
calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
at Screening (Visit 1).

Other protocol-defined criteria apply.

1. Have current or any previous history of New York Heart Associationclass III
or IV HF or left ventricular ejection fraction <30%;

2. Have been hospitalized for HF within 5 years prior to Screening (Visit 1);

3. Have had any of the following clinical events within 3 months prior to
Screening (Visit 1):
- Non-fatal MI;
- Non-fatal stroke;
- Non-elective coronary revascularization; and/or
- Hospitalization for unstable angina and/or chest pain;

4. Have uncontrolled severe hypertension, defined as either systolic blood
pressure >=160 mmHg or diastolic blood pressure >=100 mmHg
prior to Randomization, taken as the average of triplicate measurements. One
triplicate retest will be allowed during the same visit, at which point if the
retest result is no longer exclusionary, the participant may be randomized;

5. Have a formal diagnosis of homozygous familial hypercholesterolemia;

6. Have active liver disease, defined as any known current infectious,
neoplastic, or metabolic pathology of the liver; unexplained elevations in
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3× upper
limit of normal (ULN); or total bilirubin >2 × ULN at Screening (Visit 1);

7. Have an HbA1c >=10.0% or a fasting glucose >=270 mg/dL at Screening (Visit 1);

8. Have a thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1);

9. Have a creatine kinase >3 ×ULN at Screening (Visit 1);

10. Are taking gemfibrozil or have taken gemfibrozil within 30 days of
Screening (Visit 1).

Other protocol-defined criteria apply.