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

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

Condition

  • Transthyretin Amyloidosis With Cardiomyopathy

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period.
  • Drug: Nucresiran
    Nucresiran 300 mg administered SC q6M
    Other names:
    • ALN-TTRSC04
  • Drug: Sterile Normal Saline (0.9% NaCl)
    Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Experimental
Nucresiran 300 mg 		Participants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period.
  • Drug: Nucresiran
    Nucresiran 300 mg administered SC q6M
    Other names:
    • ALN-TTRSC04

Recruiting Locations

Clinical Trial Site
La Jolla, California 92037

Clinical Trial Site
Washington D.C., District of Columbia 20010

Clinical Trial Site
Brandon, Florida 33511

Clinical Trial Site
Atlanta, Georgia 30309

Clinical Trial Site
Gainesville, Georgia 30501

Clinical Trial Site
Tucker, Georgia 30084

Clinical Trial Site
Indianapolis, Indiana 46202

Clinical Trial Site
Indianapolis, Indiana 46260

Clinical Trial Site
Kansas City, Kansas 66160

Clinical Trial Site
Boston, Massachusetts 02118

Clinical Trial Site
Detroit, Michigan 48202

Clinical Trial Site
Rochester, Minnesota 55905

Clinical Trial Site
St Louis, Missouri 63110

Clinical Trial Site
Manhasset, New York 11030

Clinical Trial Site
New York, New York 10065

Clinical Trial Site
The Bronx, New York 10467

Clinical Trial Site
Charlotte, North Carolina 28204

Clinical Trial Site
Lancaster, Pennsylvania 17602

Clinical Trial Site
Philadelphia, Pennsylvania 19104

Clinical Trial Site
Dallas, Texas 75246

Clinical Trial Site
Houston, Texas 77030

Clinical Trial Site
Salt Lake City, Utah 84132

Clinical Trial Site
Charlottesville, Virginia 22903

Clinical Trial Site
Norfolk, Virginia 23507

Clinical Trial Site
Spokane, Washington 99204

More Details

NCT ID
NCT07052903
Status
Recruiting
Sponsor
Alnylam Pharmaceuticals

Study Contact

Clinical Trial Information Line
1-877-ALNYLAM
clinicaltrials@alnylam.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center