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
NewAmsterdam Pharma
Lead sponsor