Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH and LDL-C >/=70 mg/dL Who ar…

Inclusion Criteria:

• Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of > 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH)
• Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses
• Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)

Exclusion Criteria:

• New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction < 30%;
• Hospitalized for heart failure within 5 years prior to Screening
• Major adverse cardiac event (MACE) within 3 months prior to Screening;
• HbA1c ≥10%, or fasting glucose
• Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
• Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization