drugset / Trial / NCT04770389

Randomized Study of Obicetrapib in Combination With Ezetimibe

NCT04770389 ↗

Phase 2 Completed 112 enrolled NewAmsterdam Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.

Timeline

Start
2021-02-23
Primary completion
2021-05-07
Completion
2021-06-30

Outcome

Met primary endpoint

registry MEAN Combination Therapy: -45.63 (Standard Deviation 21.677) percent change from baseline NCT04770389 ↗

registry analysis (superiority test); Combination Therapy vs Placebo; p <0.0001; Least Squares (LS) Mean -44.92 (95% CI -55.20 to -34.63); Mixed Models Analysis NCT04770389 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg —
Subject Obicetrapib Small molecule 5 mg —