Phase 3 Study of Obicetrapib 10 mg and Ezetimibe 10 mg Combination or Obicetrapib Alone Added to Standard Lipid-Lowering Treatment in Adults With Type 2 Diabetes or Metabolic Syndrome

What this Trial Is About

Researchers are evaluating the effects of obicetrapib 10 mg, alone and combined with ezetimibe 10 mg, alongside standard lipid-lowering treatment in adults with metabolic syndrome andor Type 2 Diabetes Mellitus. This Phase 3, randomized, placebo-controlled, double-blind study aims to assess how these treatments affect cholesterol levels and their safety and tolerability. Participants will be assigned to one of three groups a fixed-dose combination daily of obicetrapib 10 mg plus ezetimibe 10 mg, obicetrapib 10 mg alone daily, or a placebo with standard lipid-lowering therapy. After the initial treatment period, there is an open-label extension where all may receive the combination of obicetrapib and ezetimibe. The study treatments are taken daily. During the study, participants will have their cholesterol and lipid levels measured at the start and after 84 days to evaluate changes in LDL-C and other lipid markers. The research team will monitor safety, tolerability, and other blood markers related to cholesterol. The entire study period includes initial treatment and an extension phase, with ongoing evaluations to understand how the treatments influence lipid levels and patient health.

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