Alliance for Multispecialty Research, LLC | AMR Wichita East, KS
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About
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.
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Inclusion criteria
Meets one of the following:
Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows:
Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy [LLT]) at Visit 1
Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
14,550 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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