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NCT Number: NCT07052903

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

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

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Key information

Conditions

Transthyretin Amyloidosis With Cardiomyopathy Amyloidosis Cardiomyopathies Cardiovascular Diseases Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Trial Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nucresiran

Drug

Nucresiran 300 mg administered SC q6M

Other names: ALN-TTRSC04

Sterile Normal Saline (0.9% NaCl)

Drug

Sterile Normal Saline (0.9% NaCl) administered SC once q6M

Primary outcomes

  1. Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits)

    Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

    All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model.

Secondary outcomes

  1. Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality

    Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

  2. All-cause mortality

    Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

  3. Recurrent CV events (CV hospitalizations and urgent HF visits)

    Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

  4. Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)

    Time frame: Baseline to Month 30

    The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary [OS]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Information Line

CONTACT

[email protected]

1-877-ALNYLAM

Clinical Trial Information Line

CONTACT

[email protected]

1-877-256-9526

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Jul 8, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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