CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
NCT04136171 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1438
Last updated 2025-08-08
Summary
To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC).
Conditions
- Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Interventions
- DRUG
-
Eplontersen
Eplontersen by subcutaneous injection
- DRUG
-
Eplontersen-matching placebo by subcutaneous injection
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ionis Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-13
- Primary Completion
- 2026-04-30
- Completion
- 2026-08-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Czechia
- Denmark
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Poland
- Portugal
- Puerto Rico
- Spain
- Sweden
- United Kingdom
Study Locations
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