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

Phase 2

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: MPSK3169A; Drug: Placebo

• Registration Number: NCT01609140
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	MPSK3169A	-
C	MPSK3169A	-
E	MPSK3169A	-
F	Placebo	-
A	MPSK3169A	-
D	MPSK3169A	-

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in LDL-c concentration	at Day 169

Secondary Outcome Measures

Name	Time	Method
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 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
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 and absolute change from baseline in LDL-c concentration at all other designated timepoints	at all other designated timepoints