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Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT06005597 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2025-10-08

Study results available
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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.

Conditions

Interventions

COMBINATION_PRODUCT

Combination Therapy

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

DRUG

Monotherapy obicetrapib

tablet; 10mg obicetrapib

DRUG

Monotherapy ezetimibe

capsule; 10mg ezetimibe

OTHER

Combination Therapy placebo

tablet; no active ingredient

OTHER

Obicetrapib Placebo

tablet; no active ingredient

OTHER

Ezetimibe Placebo

capsule; no active ingredient

Sponsors & Collaborators

  • NewAmsterdam Pharma

    lead INDUSTRY

Principal Investigators

  • Marc Ditmarsch, MD · NewAmsterdam Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-09-25
Completion
2024-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005597 on ClinicalTrials.gov