TRITON-CM

TRITON-CM
Enrolling By Invitation
18 years - 85 years
All
Phase N/A
10 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

Detailed description of study

This study will evaluate the efficacy, safety, pharmacokinetic, and pharmacodynamic of nucresiran in adult patients with transthyretin-mediated amyloidosis with cardiomyopathy. The study has 4 periods: Screening, Double-Blind, OLE, and Safety Follow-Up. The enrollment goal is about 1250 patients. Eligible patients have a documented diagnosis of ATTR amyloidosis with cardiomyopathy, including hATTR or wtATTR amyloidosis, and a medical history of HF with at least 1 prior hospitalization for HF.

Eligibility of study

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

  • Conditions: Medical Research
  • 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

Updated on 02 Apr 2026. Study ID: 25-1538
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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