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Clinical Trials in the USA / NCT06305559
Active, not recruiting Phase 3

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

NCT06305559 · tracked via the Priya Life Science USA tracker
Sponsor
NewAmsterdam Pharma
Phase
Phase 3
Started
2024-05-16
Last updated
2026-04-09

Condition(s) studied

LipidemiaCoronary Artery DiseasePlaque, Atherosclerotic

Investigational drug(s) / intervention(s)

obicetrapib 10 mg + ezetimibe 10 mg FDC dailyAll Obicetrapib trials (6) →All Ezetimibe FDC trials (2) →Placebo

obicetrapib 10 mg + ezetimibe 10 mg FDC daily: Active treatment

Placebo: Baseline lipid modifying therapy

Study summary

This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Fasting serum LDL-C ≥70 mg/dL (≥1.81 mmol/L) * Evaluable non-calcified plaque of at least 75 mm3 in the major epicardial coronary arteries * BMI 18-40, inclusive * Max tolerated lipid modifying therapy * Estimated glomerular filtration rate ≥40 mL/min/1.73 m2 Exclusion Criteria: * HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening * Contraindications for CCTA * History of coronary artery bypass graft * Active liver disease

Primary outcome measure(s)

  • • To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months. — 18 months
    Total plaque comparison measured by CCTA

Trial sites (1)

FacilityCityRegionStatus
NGMR Hialeah Florida

More NewAmsterdam Pharma trials in the USA

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 Active, not recruiting
Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels Recruiting
Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers Recruiting
Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease Recruiting
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease Active, not recruiting

Other trials for the same condition

AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management Active, not recruiting
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE) Active, not recruiting
RADIQAL Study (Radiation Dose and Image Quality Trial) Active, not recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) Recruiting
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06305559 on ClinicalTrials.gov ↗ ← All trials in the USA