Coronary Heart Disease
Conditions
Keywords
Hyperlipidemia, Dyslipidemia
Brief summary
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.
Interventions
DRUGMPSK3169A
Dose regimen A, repeating subcutaneous injections every 4 weeks
DRUGPlacebo
Repeating subcutaneous injections of placebo every 4 weeks
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in LDL-c concentration | at Day 169 |
Secondary
| Measure | 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 |
Countries
Canada, Czechia, Germany, Hungary, New Zealand, Norway, Slovakia, South Africa, United States
Outcome results
None listed