Atherosclerotic Cardiovascular Disease Clinical Trial
Official title:
A Randomized, Double-Blind Placebo- Controlled Phase 2a Study to Assess the Effect of CCR2 Antagonism by MLN1202 on Atherosclerotic Inflammation in Subjects With Stable Atherosclerotic Cardiovascular Disease Using FDG PET/CT Imaging
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.
The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat
people who have stable atherosclerotic cardiovascular disease (CVD). This study will look at
changes in arterial inflammation in people who take MLN1202 in addition to standard-of-care
(SOC) therapy.
The study will enroll approximately 108 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to one of the two treatment groups—which will remain
undisclosed to the patient and study doctor during the study (unless there is an urgent
medical need):
- MLN1202 Dose A intravenously (IV)
- Placebo (dummy inactive solution) - this is a solution that looks like the study drug
but has no active ingredient
All participants will receive IV administration of MLN1202 or placebo on Day 1, Day 29, and
Day 57 of this study.
This multi-centre trial will be conducted in the United States. The overall time to
participate in this study is 19 weeks. Participants will make 7 visits to the clinic, and
will be contacted by telephone approximately 35 days after last dose of study drug for a
follow-up assessment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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