CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 407 enrolled
Drug / intervention
Combination Therapy +5 morecombination
Likely dose
Combination Therapy 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/NCT06005597
NCT06005597Phase 3Completed

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors

NewAmsterdam Pharma·interventional·Posted Aug 22, 2023·Updated Oct 8, 2025

In Brief

A Phase 3 clinical trial evaluating Combination Therapy, Monotherapy obicetrapib, and 4 other interventions for Dyslipidemias and 4 related conditions. Completed, enrolled 407 participants across 45 sites.

Detailed Summary

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

Study Details

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

Timeline

Phase 3CompletedFinished
202420252026
First PostedAug 22, 2023
Enrollment StartMar 1, 2024
Primary CompletionSep 25, 2024
Study CompletionOct 16, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.9 years ago

Interventions

Combination Therapycombination

tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination

Monotherapy obicetrapibdrug

tablet; 10mg obicetrapib

Monotherapy ezetimibedrug

capsule; 10mg ezetimibe

Combination Therapy placeboother

tablet; no active ingredient

Obicetrapib Placeboother

tablet; no active ingredient

Ezetimibe Placeboother

capsule; no active ingredient