NCT07052903 TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
| NCT ID | NCT07052903 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alnylam Pharmaceuticals |
| Condition | Transthyretin Amyloidosis With Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,750 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2030-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,750 participants in total. It began in 2025-07-02 with a primary completion date of 2030-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Alnylam Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07052903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Transthyretin Amyloidosis With Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07052903 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,750 participants.
Is NCT07052903 currently recruiting?
Yes, NCT07052903 is actively recruiting participants. Contact the research team at clinicaltrials@alnylam.com for enrollment information.
Where is the NCT07052903 trial being conducted?
This trial is being conducted at La Jolla, United States, Stanford, United States, Norwich, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT07052903 clinical trial?
NCT07052903 is sponsored by Alnylam Pharmaceuticals. The principal investigator is Medical Director at Alnylam Pharmaceuticals. The trial plans to enroll 1,750 participants.