Trial Search Results

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

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Akcea Therapeutics

Collaborator: Ionis Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: ISIS 681257
  • Drug: Placebo

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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