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

Use our guide to learn which trials are right for you!

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
4085 University Boulevard South
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
Boca Raton, Florida 33434
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Cambridge, Ontario
?
mi
from
Cambridge,
Click here to add this to my saved trials
Carmichael, California 95608
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
Cooperstown, New York
?
mi
from
Cooperstown, NY
Click here to add this to my saved trials
Cottonwood, Arizona 86326
?
mi
from
Cottonwood, AZ
Click here to add this to my saved trials
Fall River, Massachusetts 02721
?
mi
from
Fall River, MA
Click here to add this to my saved trials
1303 East Herndon Avenue
Fresno, California 93721
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Greer, South Carolina 29650
?
mi
from
Greer, SC
Click here to add this to my saved trials
High Point, North Carolina 27265
?
mi
from
High Point, NC
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
3901 Rainbow Boulevard
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
La Jolla, California 92103
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lansdale, Pennsylvania 19446
?
mi
from
Lansdale, PA
Click here to add this to my saved trials
Little Rock, Arkansas
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Louisville, Kentucky 40213
?
mi
from
Louisville, KY
Click here to add this to my saved trials
3267 South 16th Street
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Montclair, California 91710
?
mi
from
Montclair, CA
Click here to add this to my saved trials
Munster, Indiana 46321
?
mi
from
Munster, IN
Click here to add this to my saved trials
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Portland, Oregon
?
mi
from
Portland, OR
Click here to add this to my saved trials
154 Waterman Street
Providence, Rhode Island 02906
?
mi
from
Providence, RI
Click here to add this to my saved trials
Wilmington, Delaware 19803
?
mi
from
Wilmington, DE
Click here to add this to my saved trials