Trial Identifiers
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Scientific Title
A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Commercial Sponsor
Ionis Pharmaceuticals, Inc.
Summary
This is a randomised, double blind trial evaluating the efficacy of eplontersen compared to placebo for 120 weeks in people with Transthyretin-Mediated Amyloid Cardiomyotherapy (ATTR-CM) receiving available standard of care (SoC). Participants will be randomly assigned to either the Experimental Arm or Placebo Comparator Arm. Participants in the Experimental Arm will receive eplontersen, administered via an injection, once every 4 weeks. Participants in the Placebo Comparator group will receive a placebo, administered via injection, once every 4 weeks. All participants will also receive daily supplemental doses of the recommended daily allowance of vitamin A.