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

Genentech

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease

Treatments: Drug: MPSK3169A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01609140

GC28210

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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248 participants in 6 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

B

Experimental group

Treatment:

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

C

Experimental group

Treatment:

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

D

Experimental group

Treatment:

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

E

Experimental group

Treatment:

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

Drug: MPSK3169A

F

Placebo Comparator group

Treatment:

Drug: Placebo