A Phase 3 interventional study of Nucresiran and Sterile Normal Saline (0.9% NaCl) in Transthyretin Amyloidosis With Cardiomyopathy, sponsored by Alnylam Pharmaceuticals. Recruiting at 266 sites in 36 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Alnylam Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to:
553 studies on the registry are indexed under Cardiomyopathies; 152 are open to participants now.
This study's planned enrollment of 1,750 is above the median of 51 across 266 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Alnylam Pharmaceuticals is the lead sponsor of 84 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period.
Drug: Nucresiran · Drug: Sterile Normal Saline (0.9% NaCl)
Participants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period.
Drug: Nucresiran
Nucresiran 300 mg administered SC q6M
Also known as: ALN-TTRSC04
Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits)
All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model.
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
All-cause mortality
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
Recurrent CV events (CV hospitalizations and urgent HF visits)
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)
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.
Time frame: Baseline to Month 30
Showing the first 100 of 266 sites across 36 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for May 2030, 58 months after the start.
Of 20 phase 3 interventional studies under Cardiomyopathies, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 103. This study's planned 58 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Nucresiran