TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
NCT07052903 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250
Last updated 2026-05-14
Summary
The purpose of this study is to:
* Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events
* Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death
* Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Conditions
Interventions
- DRUG
-
Nucresiran
Nucresiran 300 mg administered SC q6M
- DRUG
-
Sterile Normal Saline (0.9% NaCl)
Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Alnylam Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-02
- Primary Completion
- 2030-05-28
- Completion
- 2032-11-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Chile
- China
- Czechia
- Denmark
- France
- Germany
- Greece
- Hong Kong
- Hungary
- Israel
- Italy
- Japan
- Malaysia
- Netherlands
- New Zealand
- Norway
- Portugal
- Romania
- Slovakia
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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