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

Trial ID or NCT#

NCT03070782

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. Key
Exclusion Criteria:
  1. * 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
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Investigator(s)

David J. Maron
David J. Maron
Cardiologist
C. F. Rehnborg Professor and Professor of Medicine (Stanford Prevention Research Center)

View on ClinicalTrials.gov