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

a study on Cardiomyopathy

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Roxana Ghashghaei (uci)
Headshot of Roxana Ghashghaei
Roxana Ghashghaei

Description

Summary

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)

Keywords

Transthyretin Amyloidosis With Cardiomyopathy, ATTR-CM, ATTR amyloidosis with cardiomyopathy, ATTR, Heriditary ATTR, hATTR, Wild-type ATTR, wATTR, Cardiomyopathy, Amyloidosis, TTR, Transthyretin, TTR-mediated amyloidosis, RNAi, RNAi therapeutic, TTR cardiomyopathy, V122i, TTR amyloidosis, Cardiomyopathies, Nucresiran, Sterile Normal Saline (0.9% NaCl), Nucresiran 300 mg

Eligibility

You can join if…

Open to people ages 18-85

  • 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.

You CAN'T join if...

  • 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/1.73m2 at screening.
  • Has received prior or currently receiving TTR-lowering therapy

Locations

  • Clinical Trial Site accepting new patients
    La Jolla California 92037 United States
  • Clinical Trial Site accepting new patients
    Laguna Hills California 92653 United States
  • Clinical Trial Site accepting new patients
    Stanford California 94305 United States

Lead Scientist at University of California Health

  • Roxana Ghashghaei (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 18 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alnylam Pharmaceuticals
ID
NCT07052903
Phase
Phase 3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 1750 study participants
Last Updated
Contact us about this trial