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

Last updated: September 16, 2025
Sponsor: Alnylam Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Amyloidosis

Circulation Disorders

Treatment

Sterile Normal Saline (0.9% NaCl)

Nucresiran

Clinical Study ID

NCT07052903
ALN-TTRSC04-003
2024-519917-72-00
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

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

Study Design

Total Participants: 1250
Treatment Group(s): 2
Primary Treatment: Sterile Normal Saline (0.9% NaCl)
Phase: 3
Study Start date:
July 02, 2025
Estimated Completion Date:
November 30, 2032

Connect with a study center

  • Clinical Trial Site

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Clinical Trial Site

    Brandon 4148757, Florida 4155751 33511
    United States

    Active - Recruiting

  • Clinical Trial Site

    Cumming, Georgia 30041
    United States

    Site Not Available

  • Clinical Trial Site

    Cumming 4190396, Georgia 4197000 30041
    United States

    Active - Recruiting

  • Clinical Trial Site

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Active - Recruiting

  • Clinical Trial Site

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Clinical Trial Site

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Active - Recruiting

  • Clinical Trial Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

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