A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.

Official Title
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A Phase II, Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above And at least one of the following: Coronary heart disease (CHD) with a history of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or prior coronary angiography demonstrating coronary atherosclerosis A CHD risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic kidney disease, prior stroke, carotid disease, peripheral arterial disease, or abdominal aortic aneurism >/=2 CHD risk factors (age >/= 45 years for men or >/= 55 years for women; smoking; hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of a CV event based on risk estimation systems Exclusion Criteria: Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection fraction </= 35% Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG, PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac arrhythmia (other than atrial fibrillation or flutter), or initiation of renal replacement therapy (dialysis) Fasting serum triglyceride level >/= 400 mg/dL Homozygous familial hypercholesterolemia Poorly controlled diabetes mellitus, hypertension or thyroid disease Liver or muscle disease, including abnormal test results at screening Pregnant or lactating The above list is not intended to contain all factors relevant to a patient's eligibility for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: MPSK3169A<br>* Dose regimen A, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: B<br> | Drug: MPSK3169A<br>* Dose regimen B, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: C<br> | Drug: MPSK3169A<br>* Dose regimen C, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: D<br> | Drug: MPSK3169A<br>* Dose regimen D, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: E<br> | Drug: MPSK3169A<br>* Dose regimen E, repeating subcutaneous injections every 4 weeks<br>|
| Placebo Comparator: F<br> | Drug: Placebo<br>* Repeating subcutaneous injections of placebo every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in LDL-c concentration |  | at Day 169 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm |  | over the 24 week treatment period | 
| Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements |  | up to Day 169 | 
| Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm |  | at Day 169 and over the 24 week treatment period | 
| Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints |  | at all other designated timepoints | 
| Percent and absolute change from baseline in total cholesterol, non-HDL-c, and apolipoprotein B (ApoB) at Day 169 and at the nadir for each arm |  | at Day 169 and over the 24 week treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia, Dyslipidemia