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This study is a, randomized, double-blind, placebo-controlled phase 2a trial evaluating the potential of MLN1202 to reduce circulating levels of C-reactive protein (CRP)in patients with risk factors for Atherosclerotic cardiovascular disease (ASCVD). Patients with risk factors for ASCVD will be screened for inclusion and exclusion criteria including assessment of C-reactive protein. If the patient's CRP is greater than 3.0 mg/L on repeated measurements at least 2 weeks apart, the patient will be enrolled, stratified by screening CRP levels (≤5.0 mg/L and >5.0 mg/L), and randomized to receive 1 dose of either placebo or MLN1202. Safety will be assessed by vital signs, physical examination, clinical laboratories at baseline, and adverse event (AE) reporting from Day 1 to Day 113 of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLN1202 | Drug | 10 mg/kg dose of MLN1202 administered via IV infusion administered approximately 30 minutes to an hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of C-C Chemokine Receptor-2 (CCR2) blockade in reducing Creactive protein (CRP) levels in patients with risk factors for atherosclerotic cardiovascular disease (ASCVD) and a baseline elevation of CRP | The change from baseline to Day 57 in CRP between patients treated withplacebo compared with MLN1202 |
| Measure | Description | Time Frame |
|---|---|---|
| Elevation of Creactive protein (CRP) number of days from baseline until the first 1.0 mg/L decrease in CRP levels and changes from baseline to other study visits. | Baseline, Day 1 to Day 113 of the trial. |
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Inclusion Criteria:
Age of 45 years (male) or 55 years (female) or greater History of or current cigarette smoking of ≥20 pack years History of hypertension Body mass index (BMI) defined as weight (kg) divided by height (in m2) ≥30 History of hypercholesterolemia defined as fasting low-density lipoprotein >130 mg/dL History of high-density lipoprotein levels of 40 mg/dL or less Diabetes mellitus Family history of a definable ASCVD event (myocardial infarction or intervention)in a first-degree relative prior to the age of 55 (male) or 65 (female)
Exclusion Criteria:
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| Placebo | Other | Placebo consist of 0.9% saline solution administered as a 10 mg/kg dose via IV infusion administered approximately 30 minutes to an hour |
|
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558499 | plozalizumab |
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