ClinicalTrials.gov record NCT07052903
TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
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)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 3, randomized, quadruple-masked, placebo-controlled study evaluates nucresiran in people with transthyretin amyloidosis who have cardiomyopathy. Participants receive nucresiran 300 mg or placebo by subcutaneous injection every six months during the double-blind period; an open‑label extension follows in which nucresiran is given. The study compares deaths and cardiovascular events between groups and assesses patient-reported health status and quality of life.
What it is studying. The study is testing whether nucresiran given subcutaneously every six months affects a composite outcome of all-cause mortality and recurrent cardiovascular events (CV hospitalizations and urgent heart-failure visits) compared with placebo. It also evaluates time to first CV event or death, measures patient-reported health status and health-related quality of life, and assesses safety.
What the researchers hope to learn. To evaluate the efficacy and safety of nucresiran versus placebo on all-cause mortality and recurrent cardiovascular events in transthyretin amyloidosis with cardiomyopathy; to assess time to first CV event or death; and to measure effects on patient-reported health status and quality of life (for example, KCCQ scores).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Nucresiran
- Sterile Normal Saline (0.9% NaCl)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are randomized to receive subcutaneous injections every 6 months of either nucresiran 300 mg or placebo during a double-blind period, then receive nucresiran 300 mg every 6 months in an open-label extension. The study follows participants from baseline to the end of the double-blind period (estimated 32 months, up to 5 years) to record deaths, cardiovascular events, and hospital visits. Visits include the scheduled injections, health assessments and questionnaires (for example the Kansas City Cardiomyopathy Questionnaire), and (at screening only) an NT‑proBNP; hospitalizations and urgent heart‑failure visits will be tracked.
How the study is structured. Phase 3, randomized, parallel-group trial with quadruple masking (participant, care team, investigators, and outcomes assessors unaware of assignment). Participants are assigned to nucresiran 300 mg or placebo by subcutaneous injection every six months during the double-blind period (estimated ~32 months, up to 5 years), followed by an open‑label extension where all receive nucresiran.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Transthyretin Amyloidosis With Cardiomyopathy. Does it apply to my diagnosis?
- The listed sites are in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Jul 2, 2025
- Primary completion
- May 28, 2030 (estimated)
- Study completion
- Nov 30, 2032 (estimated)
- Target enrollment
- 1750 participants (estimated)
- Last updated on registry
- Sep 16, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Alnylam Pharmaceuticals
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Clinical Trial Information Line 📞 1-877-ALNYLAM ✉ clinicaltrials@alnylam.com
- Clinical Trial Information Line 📞 1-877-256-9526 ✉ clinicaltrials@alnylam.com
Participating sites (265)
- Clinical Trial SiteRecruiting
La Jolla, California, 92037 · United States
- Clinical Trial SiteRecruiting
Laguna Hills, California, 92653 · United States
- Clinical Trial SiteRecruiting
Stanford, California, 94305 · United States
- Clinical Trial SiteRecruiting
Aurora, Colorado, 80045 · United States
- Clinical Trial SiteRecruiting
Norwich, Connecticut, 06360 · United States
- Clinical Trial SiteRecruiting
Washington D.C., District of Columbia, 20010 · United States
- Clinical Trial SiteRecruiting
Brandon, Florida, 33511 · United States
- Clinical Trial SiteRecruiting
Miami, Florida, 33125 · United States
- Clinical Trial SiteRecruiting
Atlanta, Georgia, 30309 · United States
- Clinical Trial SiteRecruiting
Gainesville, Georgia, 30501 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
- estimated glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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