TRITON-CM

Study on Investigational Treatment for ATTR Amyloidosis with Cardiomyopathy

Recruiting
18 years - 85 years
All
Phase 3
1750 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Transthyretin Amyloidosis With Cardiomyopathy
  • Age: 18 years - 85 years
  • Gender: All

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

This study investigates ATTR amyloidosis with cardiomyopathy. The purpose of this study is to evaluate the effects of an investigational medication compared to a placebo.

This study evaluates the safety and effectiveness of the investigational medication on cardiovascular events and patient-reported health status.

  • Who can participate: Adults with a diagnosis of ATTR amyloidosis with cardiomyopathy can participate. Participants should have a history of heart failure and meet specific health criteria.
  • Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 23 Jul 2026. Study ID: 25-0873

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