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

Trial ID or NCT#

NCT07052903

Status

recruiting iconRECRUITING

Purpose

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

Official 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)

Eligibility Criteria

Ages Eligible for Study: 18 to 85
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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.
    1. Exclusion Criteria
  3. * 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
Exclusion Criteria:
  1. * 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
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Investigator(s)

Ronald M Witteles
Ronald M Witteles
Cardiologist, Heart failure cardiologist
Professor of Medicine (Cardiovascular Medicine)

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View on ClinicalTrials.gov