drugset / Trial / NCT07219602

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

NCT07219602

Phase 3 Recruiting 300 enrolled NewAmsterdam Pharma
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2025-12-11
Primary completion
2028-03
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Subject Obicetrapib Small molecule 10 mg