TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
NCT ID: NCT07052903
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1250 participants
INTERVENTIONAL
2025-07-02
2032-11-30
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period.
Nucresiran
Nucresiran 300 mg administered SC q6M
Sterile Normal Saline (0.9% NaCl)
Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Nucresiran 300 mg
Participants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period.
Nucresiran
Nucresiran 300 mg administered SC q6M
Interventions
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Nucresiran
Nucresiran 300 mg administered SC q6M
Sterile Normal Saline (0.9% NaCl)
Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic.
* Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \>300 ng/L and \<8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP \>600 ng/L and \<8500 ng/L.
* Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator.
Exclusion Criteria
* Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV.
* Has an estimated glomerular filtration rate eGFR of \<30 mL/min/1.73m\^2 at screening.
* Has received prior or currently receiving TTR-lowering therapy
18 Years
85 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Washington D.C., District of Columbia, United States
Clinical Trial Site
Brandon, Florida, United States
Clinical Trial Site
Gainesville, Georgia, United States
Clinical Trial Site
Tucker, Georgia, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Detroit, Michigan, United States
Clinical Trial Site
St Louis, Missouri, United States
Clinical Trial Site
Manhasset, New York, United States
Clinical Trial Site
New York, New York, United States
Clinical Trial Site
The Bronx, New York, United States
Clinical Trial Site
Philadelphia, Pennsylvania, United States
Clinical Trial Site
Dallas, Texas, United States
Clinical Trial Site
Joondalup, , Australia
Clinical Trial Site
Braunau am Inn, , Austria
Clinical Trial Site
Roeselare, , Belgium
Clinical Trial Site
Fukuoka, , Japan
Clinical Trial Site
Kobe, , Japan
Clinical Trial Site
Nankoku-Shi, , Japan
Clinical Trial Site
Okayama, , Japan
Clinical Trial Site
Sapporo, , Japan
Clinical Trial Site-1
Christchurch, , New Zealand
Clinical Trial Site-2
Christchurch, , New Zealand
Clinical Trial Site
Hamilton, , New Zealand
Clinical Trial Site
Barcelona, , Spain
Clinical Trial Site
Huelva, , Spain
Clinical Trial Site
Jaén, , Spain
Clinical Trial Site
Madrid, , Spain
Clinical Trial Site
Pamplona, , Spain
Clinical Trial Site-1
Valencia, , Spain
Clinical Trial Site-2
Valencia, , Spain
Clinical Trial Site
Basel, , Switzerland
Clinical Trial Site
Geneva, , Switzerland
Clinical Trial Site
Lucerne, , Switzerland
Clinical Trial Site
Cardiff, , United Kingdom
Clinical Trial Site
Edgbaston, , United Kingdom
Clinical Trial Site
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-519917-72-00
Identifier Type: CTIS
Identifier Source: secondary_id
ALN-TTRSC04-003
Identifier Type: -
Identifier Source: org_study_id