Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days

Korábbi kezelés

• Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
• Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and/or Hospitalization for unstable angina and/or chest pain.
• Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Screening (Visit 1);

Más betegség

• Have uncontrolled severe hypertension;
• Have active liver disease;
• Have history of full statin intolerance;

Laborértékek

• Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction <30%;
• Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);

Egyéb

• Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through genetic testing on Dutch Lipid Network criteria, Simon Broome, or MedPed;

• Are male or female and ≥18 years of age at Screening (Visit 1);
• Females may be enrolled if all 3 of the following criteria are met:
  • Are not pregnant;
  • Are not breastfeeding; and
  • Do not plan to become pregnant during the study.
• Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;
• Are on stable maximally tolerated lipid-modifying therapy for at least 8 weeks prior to Screening (Visit 1) as an adjunct to a lipid-lowering diet and lifestyle modifications, defined as a maximum tolerated statin dose, with or without ezetimibe and/or a monoclonal PCSK9-targeted therapy for at least 4 stable doses prior to Screening (Visit 1);
• Have a fasting serum LDL-C at Screening (Visit 1) of ≥70 mg/dL (1.81 mmol/L) and <130 mg/dL (3.37 mmol/L);
• Have fasting TGs <500 mg/dL (<5.7 mmol/L) at Screening (Visit 1); and
• Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).