Obicetrapib + Ezetimibe for Coronary Artery Disease
(REMBRANDT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: NewAmsterdam Pharma
Must be taking: Lipid-modifying therapy
Disqualifiers: Diabetes, Liver disease, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that participants should be on their maximum tolerated lipid-modifying therapy. This suggests you may need to continue your current lipid-modifying medications.
Is the combination of Obicetrapib and Ezetimibe safe for humans?
Research shows that Obicetrapib, when used with high-intensity statins, has an acceptable safety profile in patients with high cholesterol. Ezetimibe has also been evaluated for safety in various studies, including when combined with other cholesterol-lowering medications, and is generally considered safe.12345
What makes the drug Obicetrapib/Ezetimibe unique for treating coronary artery disease?
The drug Obicetrapib/Ezetimibe is unique because it combines two components that work together to lower cholesterol levels, which is a key factor in managing coronary artery disease. This combination may offer a novel approach compared to traditional treatments that often focus on single mechanisms or require more invasive procedures like percutaneous coronary intervention (PCI).678910
Eligibility Criteria
This trial is for adults with high-risk heart-related artery disease who aren't responding well to their current cholesterol-lowering treatments. They should have a certain amount of plaque in their arteries, a body mass index between 18-40, proper kidney function, and LDL cholesterol over 70mg/dL.Inclusion Criteria
My LDL cholesterol is above 70 mg/dL.
My kidney function is normal or only mildly reduced.
My heart's arteries have significant plaque buildup.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive obicetrapib 10 mg + ezetimibe 10 mg FDC daily or placebo for 18 months
18 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
Treatment Details
Interventions
- Obicetrapib/Ezetimibe (Lipid-lowering Agent)
Trial OverviewThe study tests if taking obicetrapib plus ezetimibe daily can change the characteristics of coronary plaque and inflammation. This is measured using advanced heart scans (CCTA). Participants are randomly chosen to either receive this combination or a placebo without knowing which one they get.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Obicetrapib/EzetimibeExperimental Treatment1 Intervention
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo on top of baseline lipid modifying therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NGMRHialeah, FL
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Who Is Running the Clinical Trial?
NewAmsterdam PharmaLead Sponsor
References
Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. [2022]Global guidelines for the management of high-cardiovascular-risk patients include aggressive goals for low-density lipoprotein cholesterol (LDL-C). Statin therapy alone is often insufficient to reach goals and nonstatin options have limitations. Here, we tested the lipid-lowering effects of the cholesteryl ester transfer protein (CETP) inhibitor drug obicetrapib in a randomized, double-blind, placebo-controlled trial in dyslipidaemic patients (n = 120, median LDL-C 88 mg dl-1) with background high-intensity statin treatment (NCT04753606). Over the course of 8 weeks, treatment with 5 mg or 10 mg obicetrapib resulted in a significant decrease as compared with placebo in median LDL-C concentration (by up to 51%; P < 0.0001), the primary trial outcome. As compared with placebo, obicetrapib treatment also significantly (P < 0.0001) decreased apolipoprotein B (by up to 30%) and non-high-density lipoprotein cholesterol (non-HDL-C) concentration (by up to 44%), and significantly (P < 0.0001) increased HDL-C concentration (by up to 165%; the secondary trial outcomes) and had an acceptable safety profile. These results support the potential of obicetrapib to address an unmet medical need for high-cardiovascular-risk patients.
Obicetrapib plus ezetimibe as an adjunct to high-intensity statin therapy: A randomized phase 2 trial. [2023]Obicetrapib, a selective cholesteryl ester transfer protein (CETP) inhibitor, reduces low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), lipoprotein particles, and apolipoproteins, when added to high-intensity statin in patients with dyslipidemia.
Lipid-Lowering Efficacy of Combination Therapy With Moderate-Intensity Statin and Ezetimibe Versus High-Intensity Statin Monotherapy: A Randomized, Open-Label, Non-Inferiority Trial From Korea. [2023]This phase IV, multicenter, randomized controlled, open-label, and parallel clinical trial aimed to compare the efficacy and safety of ezetimibe and moderate intensity rosuvastatin combination therapy to that of high intensity rosuvastatin monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD).
Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. [2015]To assess the efficacy and safety of ezetimibe coadministered with simvastatin in patients with primary hypercholesterolaemia and coronary artery disease (CAD).
Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia. [2019]This randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of ezetimibe 10 mg/day in patients with primary hypercholesterolemia.
Percutaneous coronary intervention: the story so far. [2010]Over the past two decades, the use of percutaneous coronary intervention (PCI) to treat ischemic coronary artery disease (CAD) has expanded dramatically. With new technological improvements (e.g., drug eluting stents, distal protection devices), refinements in periprocedural adjunctive pharmacology (e.g., glycoprotein IIb/IIIa [GP IIb/IIIa] inhibitors, alternative thrombin inhibitors), and better understanding of early and late outcomes, the procedural success, safety, and durability of results have improved dramatically. Increase in mortality associated with drug eluting stents has been a concern lately. Until newer randomized studies are available to fully evaluate this increase in mortality, physicians should abide by the Food and Drug Administration's guidelines for use of these stents.
Diagnosis and management of coronary artery disease. [2019]Coronary artery disease (CAD) is a major cause of morbidity and mortality in the United States. This review considers the diagnosis and therapy of CAD in the general population free of renal disease. Diagnostic methods include clinical examination, noninvasive techniques and catheterization. Pharmacological therapy includes aspirin, beta-blockers, nitrates, calcium antagonists, lipid-lowering agents, and angiotensin-converting enzyme inhibitors. Revascularization includes percutaneous coronary angioplasty and coronary artery bypass grafting. Recent clinical trials that provide the basis for current cardiology guidelines are highlighted, however individualized care is underscored.
Safety of Percutaneous Coronary Intervention Without P2Y12 Inhibitor Pretreatment From a Cohort of Unselected Patients. [2018]Recent studies have challenged systematic pretreatment with a P2Y12 inhibitor before percutaneous coronary intervention (PCI) in elective and non-ST segment elevation myocardial infarction (NSTEMI) patients. The aim of this study was to assess outcomes after performing PCI immediately after coronary angiography with an exclusive "on-the-table" P2Y12 inhibitor loading dose, by evaluating ischemic and bleeding complications in unselected patients.
Antiplatelet therapy in percutaneous coronary intervention: recent advances in oral antiplatelet agents. [2018]Dual antiplatelet therapy with aspirin and clopidogrel, in conjunction with heparin, is the most common antithrombotic strategy in percutaneous coronary intervention (PCI) used to reduce peri-procedural ischaemic complications. However, there remains significant inter-individual variability in post-treatment platelet inhibition with this current established therapy. This review focuses on recent developments in oral antiplatelet agents used in PCI, which promise to overcome, at least in part, current shortfalls.
[Double antiplatelet therapy in patients with acute coronary syndrome after percutaneous coronary intervention: individual efficacy and hemorrhagic safety of P2Y12 blockers of ticagrelor and clopidogrel in actual clinical practice]. [2019]To study the comparative efficacy and safety of clopidogrel and ticagrelor in the "double" antiplatelet therapy (DATT) in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI) in the early and late periods in real clinical practice, and to assess adherence to treatment.