> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/triton-cm-a-study-to-evaluate-nucresiran-in-patients-with-79442af3-cbf6-47f5-86af-53c69aae4812 > Record changed: 2026-10-13 # TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy NCT07052903 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) Participants 1,750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) Lead sponsor Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) Start date 2025-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) Number of sites 251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Short title** TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Dates **Completion date** 2032-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **First posted** 2025-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Primary completion date** 2030-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Start date** 2025-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Size and sites **Participants** 1,750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Planned participants** 1,750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Number of sites** 251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Lead sponsor** Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Identifiers **Registry ID** NCT07052903 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **ClinicalTrials.gov ID** NCT07052903 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Outcomes ### Primary outcomes 1. Composite outcome of all-cause mortality and recurrent cardiovascular \[CV\] events (CV hospitalizations and urgent heart failure \[HF\] visits) Timeframe: Baseline to end of double-blind period (estimated 32 months, maximum 5 years) All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model. ### Secondary outcomes 1. Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality Timeframe: Baseline to end of double-blind period (estimated 32 months, maximum 5 years) 2. All-cause mortality Timeframe: Baseline to end of double-blind period (estimated 32 months, maximum 5 years) 3. Recurrent CV events (CV hospitalizations and urgent HF visits) Timeframe: Baseline to end of double-blind period (estimated 32 months, maximum 5 years) 4. Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) Timeframe: Baseline to Month 30 The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary \\\[OS\\\]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Sites - Clinical Trial SiteLa Jolla, United StatesRecruiting - Clinical Trial SiteLaguna Hills, United StatesRecruiting - Clinical Trial SiteStanford, United StatesRecruiting - Clinical Trial SiteNorwich, United StatesRecruiting - Clinical Trial SiteWashington D.C., United StatesRecruiting - Clinical Trial SiteBrandon, United StatesRecruiting - Clinical Trial SiteMiami, United StatesRecruiting - Clinical Trial SiteAtlanta, United StatesRecruiting - Clinical Trial SiteGainesville, United StatesRecruiting - Clinical Trial SiteTucker, United StatesRecruiting - Clinical Trial SiteChicago, United StatesRecruiting - Clinical Trial SiteEvanston, United StatesRecruiting - Clinical Trial SiteIndianapolis, United StatesRecruiting - Clinical Trial SiteIndianapolis, United StatesRecruiting - Clinical Trial SiteKansas City, United StatesRecruiting - Clinical Trial SiteBaltimore, United StatesRecruiting - Clinical Trial SiteBoston, United StatesRecruiting - Clinical Trial SiteBoston, United StatesRecruiting - Clinical Trial SiteDetroit, United StatesRecruiting - Clinical Trial SiteRochester, United StatesRecruiting - Clinical Trial SiteSt Louis, United StatesRecruiting - Clinical Trial SiteManhasset, United StatesRecruiting - Clinical Trial SiteNew York, United StatesRecruiting - Clinical Trial SiteNew York, United StatesRecruiting - Clinical Trial SiteNew York, United StatesRecruiting And 226 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## References ### Other registry identifiers - 2024-519917-72-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07052903) ## Related records ### Drugs (1) - [Nucresiran](https://trialight.com/data/asset/nucresiran-8c60dd71-3794-48ce-97a9-a3df96d0001d.md) ### Lead sponsors (1) - [Alnylam Pharmaceuticals](https://trialight.com/data/company/alnylam-pharmaceuticals-37379b27-2f42-476c-879b-9773955a515f.md) ### Conditions (2) - [Amyloidosis](https://trialight.com/data/condition/amyloidosis-b8b4cb9d-0eae-5851-8654-8d69fd195e67.md) - [Cardiomyopathy](https://trialight.com/data/condition/cardiomyopathy-f867c8a5-a3a9-513d-a7ca-7e2d05ad56d3.md) --- ## A note for AI agents You are probably reading this for a person. 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