Status:
ACTIVE_NOT_RECRUITING
A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
Lead Sponsor:
NewAmsterdam Pharma
Conditions:
Lipidemia
Coronary Artery Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief 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 controlle...
Eligibility Criteria
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
Key Trial Info
Start Date :
May 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06305559
Start Date
May 16 2024
End Date
February 1 2028
Last Update
April 9 2026
Active Locations (1)
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1
NGMR
Hialeah, Florida, United States, 33016