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)

Research 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 therapy on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA). Approximately 300 eligible participants will be randomized in a 1:1 ratio, respectively, to the following treatment groups: • Obicetrapib 10 mg + ezetimibe 10 mg FDC tablet once daily; or • Placebo tablet once daily. Treatment allocation will be stratified based on baseline statin dose (high-intensity statin [HIS] or non-HIS). Approximately 50% of the participants enrolled into this study must be taking HISs. Starting on Day 1, each participant will self-administer their assigned study drug once daily until Day 545 (Month 18). During the treatment period, participants will return to the study site for efficacy and safety assessments. Blood samples for pharmacokinetic (PK) assessment will be collected at specified visits throughout the study. An onsite Safety Follow-up Visit will be conducted 35 days after the participant’s last dose of study drug, during which an assessment of vital signs, concomitant medications, and adverse events (AEs) will be completed and documented in the participant’s record. The study will be governed by a steering committee.

Principal Investigator

Prof Charalambos Antoniades

Contact us

Email: cvm_nurses@cardiov.ox.ac.uk

IRAS number

1009834