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TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy | Clinical Trials | Clareo Health

RECRUITINGPHASE3

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

NCT07052903•Alnylam Pharmaceuticals

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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

Locations (157)

Clinical Trial Site

La Jolla, California, United States

Clinical Trial Site

Washington D.C., District of Columbia, United States

Clinical Trial Site

Brandon, Florida, United States

Clinical Trial Site

Atlanta, Georgia, United States

Clinical Trial Site

Gainesville, Georgia, United States

Clinical Trial Site

Tucker, Georgia, United States

Clinical Trial Site

Indianapolis, Indiana, United States

Clinical Trial Site

Indianapolis, Indiana, United States

Clinical Trial Site

Kansas City, Kansas, United States

Clinical Trial Site

Boston, Massachusetts, United States

Key Dates

Start Date

July 2, 2025

Primary Completion Date

May 28, 2030

Completion Date

November 30, 2032

Last Updated

February 17, 2026

Enrollment

1,250

ESTIMATED participants

Conditions

Transthyretin Amyloidosis With Cardiomyopathy

Interventions

Nucresiran

DRUG

Sterile Normal Saline (0.9% NaCl)

DRUG

Contacts

Clinical Trial Information Line

CONTACT

1-877-ALNYLAM clinicaltrials@alnylam.com

Clinical Trial Information Line

CONTACT

1-877-256-9526 clinicaltrials@alnylam.com

DemonsTTRate: A Global, Observational, Multicenter, Long-term Study of Patients With ATTR-CM in a Real-World Setting

NCT07358078

Transthyretin Amyloidosis With Cardiomyopathy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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