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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lipidemia, Coronary Artery Disease, Plaque, Atherosclerotic

In brief

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).

Key facts

Study ID

NCT06305559

Run by

NewAmsterdam Pharma

People needed

300

Starts

2024-05-16

Expected to finish

2028-02-01

Last updated by the study team

2026-04-09

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NGMR — Hialeah, Florida, United States

Full record on ClinicalTrials.gov

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