Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Patients With Hyperlipoproteinemia(a) and Cardiovascular Disease



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:12/15/2018
Start Date:March 7, 2017
End Date:November 13, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) Administered Subcutaneously to Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease (CVD)

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to
evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of
different doses and dosing regimens of ISIS 681257 for reduction of plasma Lp(a) levels in
patients with hyperlipoproteinemia(a) and established cardiovascular disease (CVD).


Key Inclusion Criteria:

- Clinical diagnosis of CVD defined as documented coronary artery disease, stroke, or
peripheral artery disease

- Lp(a) plasma level ≥ 60 mg/dL

- Must be on standard-of-care preventative therapy for other than elevated Lp(a) CVD
risk factors

Key Exclusion Criteria:

- Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or
stroke/TIA

- Within 3 months of Screening: coronary, carotid, or peripheral arterial
revascularization, major non-cardiac surgery, or lipoprotein apheresis

- Heart failure New York Heart Association (NYHA) class IV
We found this trial at
22
sites
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Baltimore, Maryland
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Boca Raton, Florida 33434
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Boston, Massachusetts 02114
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Boston, MA
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Chicoutimi, Quebec
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Cleveland, Ohio 44195
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525 Bob Peters Grove
Colorado Springs, Colorado 80909
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Cooperstown, New York
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Cottonwood, Arizona 86326
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Falls Church, Virginia
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Falls Church, VA
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Houston, Texas 77030
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Houston, TX
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Huntington Beach, California 92647
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4085 University Boulevard South
Jacksonville, Florida 32216
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
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La Jolla, California 92103
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36 East King Street
Lancaster, Pennsylvania 17602
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Los Angeles, California 90033
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3267 South 16th Street
Milwaukee, Wisconsin 53215
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New York, New York 10032
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Philadelphia, Pennsylvania 19104
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Portland, Oregon
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Portland, OR
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154 Waterman Street
Providence, Rhode Island 02906
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Stanford, California
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Stanford, CA
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