This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy.
The primary objective is to compare the LDL-C lowering effect of OBI (a CETP inhibitor) against BPA at 12 weeks
Are male or female and ≥18 years of age at Screening (Visit 1);
Are not pregnant;
Are not breastfeeding; and
Do not plan to become pregnant during the study.
Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction <30%;
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 uncontrolled severe hypertension;
Parallel
Obicetrapib 10 mg/Bempedoic Acid Placebo
DrugOrally, Once Daily
Bempedoic Acid 180mg/Placebo Obicetrapib
DrugOrally, Once Daily
The primary efficacy endpoint is the percentage change from baseline to Day 84 in LDL-C in the OBI group compared to the BPA group.
Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group
Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group;
Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group;
Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;
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A. Menarini International Licensing S.A.
Lead sponsor
Medpace, Inc.
Collaborator
