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

StatusRecruiting
PhasePhase 3
Started2025-07-02
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Trial sites expanded: 251 → 265 locations
2026-08-12
Study Status, Contacts/Locations v13
Trial sites expanded: 240 → 251 locations
2026-07-22
Study Status, Study Design, Eligibility, Contacts/Locations v12
Enrollment increased: 1250 → 1750 participants
Trial sites expanded: 233 → 240 locations
Eligibility criteria+2 characters
[...] a, 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
2026-06-10
Study Status, Contacts/Locations v11
Trial sites expanded: 223 → 233 locations
2026-05-12
Study Status, Contacts/Locations v10
Trial sites expanded: 207 → 223 locations
2026-04-16
Study Status, Contacts/Locations v9
Trial sites expanded: 157 → 207 locations
2026-03-30
Study Status v8
Re-verified, no change to tracked fields
2026-02-13
Study Status, Contacts/Locations v7
Study sites59→157
2025-12-18
Study Status, Contacts/Locations v6
Study sites36→59
2025-11-12
Study Status, Contacts/Locations v5
Study sites17→36
2025-10-16
Study Status, Contacts/Locations v4
Study sites6→17
2025-09-16
Study Status, Contacts/Locations v3
Study sites3→6
2025-08-27
Study Status, Contacts/Locations, IPDSharing v2
Study sites2→3
2025-07-11
Study Status, Eligibility v1
Start dateestimated 2025-07-01→confirmed 2025-07-02
Eligibility criteria+64 characters
[...] 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 pep [...] F at the discretion of the Investigator. Exclusion Criteria Has New York Heart Association (NYHA) Class IV HF; or NYHA Class [...]
2025-06-30
Original filing
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
Trial Details
NCT Number NCT07052903
Lead Sponsor Alnylam Pharmaceuticals
Conditions Transthyretin Amyloidosis With Cardiomyopathy
Enrollment 1,750 participants
Start Date 2025-07-02
Primary Completion 2030-05-28 (estimated)
Study Completion 2032-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-16