This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.
fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)
Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and <400 mg/dL (<4.5 mmol/L)
Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and <400 mg/dL (<4.5 mmol/L) and at least 2 risk factors
Are on stable guideline-recommended lipid-lowering therapy
Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction <30%
Have been hospitalized for heart failure within 5 years prior to Screening
Have uncontrolled severe hypertension
Have a formal diagnosis of homozygous familial hypercholesterolemia
Parallel
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
DrugFDC
Obicetrapib 10 mg
Drugmonotherapy
Placebo
Other interventionplacebo on top of guideline-recommended lipid modifying therapy
The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group
Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Percent change from Baseline over time in LDL-C
The percent change from Baseline at every visit for LDL-C
Proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L)
The percent change from Baseline at every visit in the proportion of participants that achieve LDL-C \<100 mg/dL (\<2.6 mmol/L), LDL-C \<70 mg/dL (\<1.8 mmol/L), and LDL-C \<55 mg/dL (\<1.4 mmol/L)
Percent change from Baseline over time in non-HDL-C
The percent change from Baseline at every visit for non-HDL-C
Percent change from Baseline over time in ApoB
The percent change from Baseline at every visit in ApoB
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