What is nucresiran studying for transthyretin amyloidosis with cardiomyopathy?

Nucresiran is being studied to see if it can reduce death and heart-related events in patients with transthyretin amyloidosis with cardiomyopathy. Researchers want to understand how this treatment compares to a placebo in improving patient health and quality of life. The study is sponsored by Alnylam Pharmaceuticals.

Who may be eligible for this transthyretin amyloidosis with cardiomyopathy clinical trial?

Adults aged 18 to 85 years with a diagnosis of transthyretin amyloidosis and cardiomyopathy may be eligible. Participants should have a history of heart failure with at least one prior hospitalization or symptoms needing diuretic treatment. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this transthyretin amyloidosis with cardiomyopathy clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 18Years - 85Years

All Genders

ID07052903

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

Led by Alnylam Pharmaceuticals · Updated on 2026-05-14

1250

Participants Needed

223

Research Sites

131 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating nucresiran in patients with transthyretin amyloidosis who have cardiomyopathy. The study aims to compare the effects of nucresiran versus a placebo on reducing death from any cause and cardiovascular events, as well as assessing patient-reported health status and quality of life. This is a Phase 3, global, randomized, double-blind study sponsored by Alnylam Pharmaceuticals. Participants receive either nucresiran 300 mg or a placebo injected under the skin every six months during the double-blind period. After this, all participants enter an open-label extension where they receive nucresiran 300 mg every six months. The study treatments are given subcutaneously and the double-blind phase is estimated to last about 32 months, with a possible maximum of 5 years. During the study, participants will be monitored for all-cause mortality and cardiovascular events such as hospitalizations and urgent heart failure visits. Quality of life and health status will be assessed using the Kansas City Cardiomyopathy Questionnaire. Regular evaluations include tracking recurrent cardiovascular events and changes in heart failure symptoms. Safety and health will be followed throughout the double-blind and extension periods, with a maximum participation length of about 5 years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including hereditary ATTR or wild-type ATTR amyloidosis
Has medical history of heart failure with at least 1 prior hospitalization for heart failure or symptoms requiring diuretic treatment
Has screening NT-proBNP >300 ng/L and <8500 ng/L; if atrial fibrillation is present, NT-proBNP >600 ng/L and <8500 ng/L
May be receiving approved TTR stabilizers for ATTR amyloidosis and background heart failure therapy at investigator discretion

You will not qualify if you...

Has New York Heart Association Class IV heart failure, or Class III heart failure with ATTR amyloidosis Disease Stage 3
Has polyneuropathy disability Score IIIa, IIIb, or IV
Has estimated glomerular filtration rate less than 30 mL/min/1.73m2 at screening
Has received or is currently receiving TTR-lowering therapy

Research Team

Clinical Trial Information Line

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