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

NCT01609140 | Completed Phase 2

• 1 other identifier: GC28210
• Study Type: interventional
• Target: 248
• Locations: 9 countries
• Sites: 73

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.

Conditions

Coronary Heart Disease

Keywords

Hyperlipidemia; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in LDL-c concentration

  at Day 169

Secondary Outcomes (5)

• 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

Study Arms (6)

A

EXPERIMENTAL

Drug: MPSK3169A

B

EXPERIMENTAL

Drug: MPSK3169A

C

EXPERIMENTAL

Drug: MPSK3169A

D

EXPERIMENTAL

Drug: MPSK3169A

E

EXPERIMENTAL

Drug: MPSK3169A

F

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MPSK3169A DRUG

Dose regimen A, repeating subcutaneous injections every 4 weeks

A

Placebo DRUG

Repeating subcutaneous injections of placebo every 4 weeks

F

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (73)

Unknown Facility

Goodyear, Arizona, 85395, United States

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Carmichael, California, 95608, United States

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Spring Valley, California, 91978, United States

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Walnut Creek, California, 94598, United States

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Wildomar, California, 92595, United States

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Jacksonville, Florida, 32216, United States

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Ponte Verde, Florida, 32081, United States

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Boise, Idaho, 83704, United States

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Indianapolis, Indiana, 46260, United States

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Iowa City, Iowa, 52242, United States

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Auburn, Maine, 04210, United States

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Baltimore, Maryland, 21209, United States

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Bethesda, Maryland, 20817, United States

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St Louis, Missouri, 63110, United States

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Rochester, New York, 14609, United States

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Wilmington, North Carolina, 28401, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45212, United States

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Cincinnati, Ohio, 45219, United States

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Springdale, Ohio, 45246, United States

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Oklahoma City, Oklahoma, 73103, United States

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Tulsa, Oklahoma, 74136, United States

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Greer, South Carolina, 29650, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Spartanburg, South Carolina, 29303, United States

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Rapid City, South Dakota, 57701, United States

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Bristol, Tennessee, 37620, United States

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Knoxville, Tennessee, 27912, United States

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Boerne, Texas, 78006, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77030, United States

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Richmond, Virginia, 23294, United States

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Wenatchee, Washington, 98801, United States

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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada

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St. John's, Newfoundland and Labrador, A1A 3R5, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Woodstock, Ontario, N4S 5P5, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H2P 2M1, Canada

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Hodonín, 695 01, Czechia

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Jičícin, 50601, Czechia

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Mariánské Lázně, 353 01, Czechia

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Ostrava - Poruba, 708 52, Czechia

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Rakovník, 269 01, Czechia

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Berlin, 13125, Germany

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Cologne, 50937, Germany

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Komárom, 2921, Hungary

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Nagykanizsa, 8800, Hungary

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Nyíregyháza, 4400, Hungary

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Sopron, 9400, Hungary

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Auckland, 1001, New Zealand

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Auckland, New Zealand

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Christchurch, 8011, New Zealand

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Nelson, 7001, New Zealand

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Tauranga, 3110, New Zealand

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Elverum, 2401, Norway

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Hamar, 2317, Norway

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Oslo, 0027, Norway

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Oslo, 0160, Norway

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Sandnes, 4313, Norway

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Bardejov, 08501, Slovakia

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Bratislava, 841 07, Slovakia

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Prešov, 080 01, Slovakia

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Rimavská Sobota, 979 01, Slovakia

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Cape Town, 7130, South Africa

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Cape Town, 7505, South Africa

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Centurion, 0157, South Africa

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Pretoria, 0181, South Africa

Location

Related Publications (1)

• Baruch A, Mosesova S, Davis JD, Budha N, Vilimovskij A, Kahn R, Peng K, Cowan KJ, Harris LP, Gelzleichter T, Lehrer J, Davis JC Jr, Tingley WG. Effects of RG7652, a Monoclonal Antibody Against PCSK9, on LDL-C, LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or With Established Coronary Heart Disease (from the Phase 2 EQUATOR Study). Am J Cardiol. 2017 May 15;119(10):1576-1583. doi: 10.1016/j.amjcard.2017.02.020. Epub 2017 Mar 1.

  PMID: 28343601 DERIVED

MeSH Terms

Conditions

Coronary Disease; Hyperlipidemias; Dyslipidemias

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

HU (4); NO (5); CA (10); DE (2); CZ (5); ZA (4); US (34); NZ (5); SL (4)