The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving standard-of-care (SOC) therapy.
Name: MLN1202
Name: Placebo
Description: The primary imaging endpoint of interest is the FDG uptake, measured as a target to background ratio (TBR) within the most diseased segment (MDS) of the index vessel.
Measure: The change in arterial FDG uptake from MLN1202 treatment relative to placebo, comparing pretreatment and 3 month post-treatment time points Time: Baseline and 3 month post-treatmentDescription: Average mean of the maximum TBR in the MDS of the combined right and left carotid artery walls will be measured using 2-deoxy-2-[18F]-fluoro-D-g1ucose positron emission tomography/computed tomography (FDG PET/CT).
Measure: Change from Baseline in Mean Carotid Vessel MDS TBR Time: Baseline and Day 82Description: TBR will be measured in both ascending aorta and carotids with demonstrable inflammation at Baseline using FDG PET/CT.
Measure: Change from Baseline in Mean Active Segment TBR Time: Baseline and Day 82Description: FDG uptake in the artery wall within the entire index vessel will be measured using FDG PET/CT.
Measure: Change from Baseline in Mean Index Vessel TBR Time: Baseline and Day 82Description: The average mean of the maximum TBR and the MDS of the combined right and left carotid artery walls will be measured using FDG PET/CT.
Measure: Change from Baseline in Mean Carotid Vessel TBR Time: Baseline and Day 82Allocation: Randomized
Parallel Assignment
There is one SNP
The change in arterial FDG uptake from MLN1202 treatment relative to placebo, comparing pretreatment and 3 month post-treatment time points in subjects identified using a dominant model of the snip in the MCP-1 polymorphisms [MCP-1 -2518 (rs1024611)].. null.