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

• Status: Completed
• Trial end date: 2018-11-13
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akcea Therapeutics; Ionis Pharmaceuticals, Inc.
• Collaborators: Akcea Therapeutics; Ionis Pharmaceuticals, Inc.

Criteria

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