A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and 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 (RUBENS Trial)
NewAmsterdam Pharma
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 hosp…
Interventions
- Drugobicetrapib 10 mg + ezetimibe 10 mg FDC daily
FDC
- DrugObicetrapib 10 mg
monotherapy
- OtherPlacebo
placebo on top of guideline-recommended lipid modifying therapy
Locations (20)
- Clinical Research Institute of ArizonaSun City West, Arizona
- Scripps Health - Whittier Diabetes InstituteLa Jolla, California
- UF Health JacksonJacksonville, Florida
- East Coast Institute of Research LLCJacksonville, Florida
- East Coast Institute of Research LLCLake City, Florida
- Floridian Clinical ResearchMiami Lakes, Florida