A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome

Summary

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.

Eligibility

Inclusion Criteria:

* 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
* Estimated glomerular filtration rate ≥15 mL/min/1.73 m2

Exclusion Criteria:

* 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
* HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
* active liver disease

Conditions4

Interventions2

Locations20 sites

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