TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Transthyretin Amyloidosis With Cardiomyopathy
In brief
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
Key facts
- Study ID
- NCT07052903
- Run by
- Alnylam Pharmaceuticals
- People needed
- 1750
- Starts
- 2025-07-02
- Expected to finish
- 2032-11-30
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis.
- 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.
You may not qualify if…
- Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3.
- 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
Where it is running
- Clinical Trial Site — Stanford, California, United States (enrolling)
- Clinical Trial Site — Norwich, Connecticut, United States (enrolling)
- Clinical Trial Site — Washington D.C., District of Columbia, United States (enrolling)
- Clinical Trial Site — Brandon, Florida, United States (enrolling)
- Clinical Trial Site — Miami, Florida, United States (enrolling)
- Clinical Trial Site — Atlanta, Georgia, United States (enrolling)
- Clinical Trial Site — Gainesville, Georgia, United States (enrolling)
- Clinical Trial Site — Tucker, Georgia, United States (enrolling)
- Clinical Trial Site — Evanston, Illinois, United States (enrolling)
- Clinical Trial Site — Indianapolis, Indiana, United States (enrolling)
- Clinical Trial Site — Indianapolis, Indiana, United States (enrolling)
- Clinical Trial Site — Kansas City, Kansas, United States (enrolling)
- Clinical Trial Site — Baltimore, Maryland, United States (enrolling)
- Clinical Trial Site — Boston, Massachusetts, United States (enrolling)
- Clinical Trial Site — Boston, Massachusetts, United States (enrolling)
- Clinical Trial Site — Detroit, Michigan, United States (enrolling)
- Clinical Trial Site — Rochester, Minnesota, United States (enrolling)
- Clinical Trial Site — St Louis, Missouri, United States (enrolling)
- Clinical Trial Site — Manhasset, New York, United States (enrolling)
- Clinical Trial Site — New York, New York, United States (enrolling)
- Clinical Trial Site — New York, New York, United States (enrolling)
- Clinical Trial Site — New York, New York, United States (enrolling)
- Clinical Trial Site — The Bronx, New York, United States (enrolling)
- Clinical Trial Site — Charlotte, North Carolina, United States (enrolling)
- Clinical Trial Site — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
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