Status:
COMPLETED
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
Lead Sponsor:
Akcea Therapeutics
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Hypertriglyceridemia
Cardiovascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This was 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 an...
Eligibility Criteria
Inclusion
- Key
- Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or peripheral artery disease).
- Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equal to (≤) 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
- Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/transient ischemic attack (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.
- Glycated hemoglobin (HbA1c) ≥ 9.0% at Screening.
- Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of new medication within 12 weeks of Screening \[with the exception of ± 10 units of insulin\].
- Body Mass Index (BMI) greater than (\>) 40 kilograms per square meter (kg/m\^2).
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03385239
Start Date
January 30 2018
End Date
February 25 2020
Last Update
January 11 2023
Active Locations (31)
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1
Clinical Site
Cottonwood, Arizona, United States, 86326
2
Clinical Site
Little Rock, Arkansas, United States, 72205
3
Clinical Site
Carmichael, California, United States, 95608
4
Clinical Site
Fresno, California, United States, 93720