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

Not 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
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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305