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Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
Recruiting
Trial ID: NCT03070782
Purpose
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 Lipoprotein(a)
[Lp(a)] levels in participants with hyperlipoproteinemia(a) and established cardiovascular
disease (CVD).
Official Title
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)
Stanford Investigator(s)
David J. Maron
C. F. Rehnborg Professor and Professor of Medicine (Stanford Prevention Research Center)
Eligibility
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
Intervention(s):
drug: ISIS 681257
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305