Transthyretin Amyloidosis With Cardio...

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

About this trial

Last updated 17 days ago

Study ID

ALN-TTRSC04-003

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Accepting

18 to 85 Years

All Sexes

Trial Timing

Started 10 months ago

What is this trial about?

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

What are the participation requirements?

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

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For more information, view the full study details:

NCT07052903