TRITON-CM: A Study to Evaluate an investigational medication in Patients With Transthyretin Amyloidosis With Cardiomyopathy
- Study IRB#:2000040664
- Last Updated:04/21/2026
A Phase 3, global, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and PD of nucresiran in adult patients with ATTR amyloidosis (hereditary or wild type) with cardiomyopathy. The study consists of 4 periods: Screening Period (screening assessment that will last up to 45 days), Double-blind period (Eligible patients will be randomized in a 2:1 ratio on Day 1 to receive 300 mg of nucresiran or placebo via SC injection once every 6 months), Open-label extension(OLE) period (Open-label Extension (OLE) Period: Up to 2 years during which all patients will receive 300 mg of nucresiran via Subcutaneous injection every 6 months), and the Safety Follow-up period (scheduled assessments that may be completed from 6 to 24 months, depending on the discontinuation status).
- Age18 years - 85 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Cinthia de Freitas
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Trial Purpose and Description
A Phase 3, global, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and PD of nucresiran in adult patients with ATTR amyloidosis (hereditary or wild type) with cardiomyopathy. The study consists of 4 periods: Screening Period (screening assessment that will last up to 45 days), Double-blind period (Eligible patients will be randomized in a 2:1 ratio on Day 1 to receive 300 mg of nucresiran or placebo via SC injection once every 6 months), Open-label extension(OLE) period (Open-label Extension (OLE) Period: Up to 2 years during which all patients will receive 300 mg of nucresiran via Subcutaneous injection every 6 months), and the Safety Follow-up period (scheduled assessments that may be completed from 6 to 24 months, depending on the discontinuation status).
Eligibility Criteria
- Male or female
- Age 18 to 85
- Diagnosis of ATTR amyloidosis with cardiomyopathy
- Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic
For qualification, additional eligibility criteria will be reviewed by the study team.
