A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk (MEDICI Study)

Conditions

Dyslipidemia at High to Very High Cardiovascular Risk

Brief summary

1. 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.

Detailed description

1. Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group, 2. Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group, 3. Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group, 4. Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;, 5. Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; and, 6. Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group, 7. Overall proportion of participants in the OBI group compared to the BPA group achieving their CV risk-based LDL-C goals, defined as: o High CV risk participants at Day 84 who achieved LDL-C <70 mg/dL (<1.8 mmol/L); and o Very high CV risk participants at Day 84 who achieved LDL-C <55 mg/dL (<1.4 mmol/L)., 8. Safety and tolerability profile of OBI and BPA assessed by AEs, ESIs, physical examinations, vital signs, and clinical laboratory values.

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Interventions

DRUGNilemdo 180 mg film-coated tablets

DRUGBempedoic acid matching placebo

DRUGObicetrapib

DRUGObicetrapib matching placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. 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.	—

Secondary

Measure	Time frame
1. Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group, 2. Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group, 3. Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group, 4. Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;, 5. Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; and, 6. Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group, 7. Overall proportion of participants in the OBI group compared to the BPA group achieving their CV risk-based LDL-C goals, defined as: o High CV risk participants at Day 84 who achieved LDL-C <70 mg/dL (<1.8 mmol/L); and o Very high CV risk participants at Day 84 who achieved LDL-C <55 mg/dL (<1.4 mmol/L)., 8. Safety and tolerability profile of OBI and BPA assessed by AEs, ESIs, physical examinations,	—

Measure

Time frame

1. Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group, 2. Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group, 3. Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group, 4. Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;, 5. Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; and, 6. Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group, 7. Overall proportion of participants in the OBI group compared to the BPA group achieving their CV risk-based LDL-C goals, defined as: o High CV risk participants at Day 84 who achieved LDL-C <70 mg/dL (<1.8 mmol/L); and o Very high CV risk participants at Day 84 who achieved LDL-C <55 mg/dL (<1.4 mmol/L)., 8. Safety and tolerability profile of OBI and BPA assessed by AEs, ESIs, physical examinations,

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Outcome results

None listed