CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 119 enrolled
Drug / intervention
Obicetrapib +3 moredrug
Likely dose
Ezetimibe 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05266586
NCT05266586Phase 2Completed

A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study

NewAmsterdam Pharma·interventional·Posted Mar 4, 2022·Updated Jul 3, 2024

In Brief

A Phase 2 clinical trial evaluating Obicetrapib, Ezetimibe 10mg, and 2 other interventions for Dyslipidemias and 2 related conditions. Completed, enrolled 119 participants across 16 sites.

Detailed Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 4, 2022
Enrollment StartMar 9, 2022
Primary CompletionAug 12, 2022
Study CompletionSep 8, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.3 years ago

Interventions

Obicetrapibdrug

tablets

Ezetimibe 10mgdrug

capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Obicetrapib placeboother

tablets; no active ingredient

Ezetimibe placeboother

capsules; no active ingredient