A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib/Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants With Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT Trial)
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
NGMR
RECRUITING
Hialeah
Contact Information
Primary
Global Clinical Trial Lead
shayleen.vanvuuren@fortrea.com
+27 82 495 9889
Backup
Claudia Forkel
+49 151 64549618
Time Frame
Start Date: 2024-05-16
Estimated Completion Date: 2027-03
Participants
Target number of participants: 300
Treatments
Experimental: Obicetrapib/Ezetimibe
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Placebo_comparator: Placebo
Placebo on top of baseline lipid modifying therapy
Related Therapeutic Areas
Sponsors
Leads: NewAmsterdam Pharma