Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)



Status:Recruiting
Conditions:High Cholesterol, Peripheral Vascular Disease, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Pharmacology / Toxicology
Healthy:No
Age Range:18 - 80
Updated:12/15/2018
Start Date:January 5, 2018
End Date:May 31, 2019
Contact:Akcea Therapeutics
Email:cjensen@akceatx.com
Phone:617-207-0297

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A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 678354 Administered Subcutaneously to Patients With Hypertriglyceridemia 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 678354 and to assess the efficacy of
different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG)
levels in patients with hypertriglyceridemia and established CVD.


Key Inclusion Criteria:

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

- Fasting serum TG ≥ 200 mg/dL (≥ 2.3 mmol/L) and ≤ 500 mg/dL (≥ 5.7 mmol/L) at
Screening.

- Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit.

- Must be on standard-of-care preventative therapy for known 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

- Type 1 diabetes mellitus

- Type 2 diabetes mellitus with any of the following:

- Newly diagnosed within 12 weeks of screening

- HbA1c ≥ 9.0% at Screening

- Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of
new medication within 12 weeks of screening [with the exception of ± 10 units of
insulin

- BMI > 40 kg/m2
We found this trial at
25
sites
3267 South 16th Street
Milwaukee, Wisconsin 53215
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Ames, Iowa 50010
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Ames, IA
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Boca Raton, Florida 33434
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Boca Raton, FL
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Cambridge, Ontario
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Cambridge,
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Carmichael, California 95608
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Carmichael, CA
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Cooperstown, New York
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Cooperstown, NY
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Cottonwood, Arizona 86326
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Cottonwood, AZ
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Fall River, Massachusetts 02721
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Fall River, MA
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1303 East Herndon Avenue
Fresno, California 93721
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Fresno, CA
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Greer, South Carolina 29650
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Greer, SC
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High Point, North Carolina 27265
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High Point, NC
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Houston, Texas 77030
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Houston, TX
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4085 University Boulevard South
Jacksonville, Florida 32216
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Jacksonville, FL
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
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Kansas City, KS
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La Jolla, California 92103
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La Jolla, CA
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Lansdale, Pennsylvania 19446
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Lansdale, PA
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Little Rock, Arkansas
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Little Rock, AR
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Long Beach, California
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Long Beach, CA
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Louisville, Kentucky 40213
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Louisville, KY
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Montclair, California 91710
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Montclair, CA
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Munster, Indiana 46321
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Munster, IN
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New Port Richey, Florida 34652
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New Port Richey, FL
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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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Providence, RI
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Wilmington, Delaware 19803
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Wilmington, DE
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