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

Launched by NEWAMSTERDAM PHARMA · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new medication combination, obicetrapib and ezetimibe, on heart health, specifically looking at coronary plaque and inflammation in patients who have high-risk heart disease and are not getting enough control from their current cholesterol treatments. The trial is called a Phase 3 study, which means it's one of the final stages of testing before the treatment can be considered for approval. Participants will undergo special heart imaging tests to see how the medication affects their coronary arteries over time.

To be eligible for this trial, you need to be an adult with high cholesterol that isn't well managed by your current medication, and you should have specific measurements in your blood tests and heart imaging. The trial is open to people aged 16 and older, regardless of gender. If you join the study, you'll take the medication daily and attend regular check-ups to monitor your health. This trial is currently recruiting participants, so if you meet the criteria, it could be an opportunity to help yourself and others in the fight against heart disease.

Gender

ALL

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