Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Inclusion Criteria

• Females may be enrolled if all 3 of the following criteria are met:
• They are not pregnant;
• They are not breastfeeding; and
• They do not plan on becoming pregnant during the study;
• Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD
• 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 for at least 8 weeks prior to Screening
• Atorvastatin 40 and 80 mg; and
• Rosuvastatin 20 and 40 mg;
• Ezetimibe with or without maximally tolerated statin for at least 8 weeks prior to Screening
• Bempedoic acid with a maximally tolerated statin for at least 8 weeks prior to Screening
• A PCSK-9 targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening
• Have a fasting serum LDL-C at Screening as follows:
• Fasting serum LDL-C ≥ 55 to 3 and 60 years;
• High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L (≥19.0 nmol/L) at Screening or within 6 months prior to Screening
• Fasting triglycerides (TG) > 150 mg/dL (>1.7 mmol/L);
• Fasting lipoprotein (a) > 30 mg/dL (>70 nmol/L); and/or
• Fasting HDL-C 1.5 X upper limit of normal (ULN) at Screening;
• Creatine kinase > 3 X upper limit of normal (ULN) at Screening;
• History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization;
• Known history of alcohol and/or drug abuse within 5 years prior to Randomization
• Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer;
• Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening
• Planned use of other investigational products or devices during the course of the study;
• Participated in any clinical trial evaluating obicetrapib; or
• Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
• Any condition that, according to the Investigator, could interfere with the conduct of the study