Tests nucresiran against placebo in people with transthyretin amyloidosis heart disease
Tests nucresiran against a placebo in adults with heart disease from transthyretin amyloidosis.
Key facts
- Who runs it
- Alnylam Pharmaceuticals
- Where
- Braunau Am Inn, Graz, Vienna, and Wels, AustriaSee the 6 sitesAlso in 35 other countries, 238 sites
- Trial code
- Registry title
- TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,750 people, planned
- Started
- 2 Jul 2025
- Expected to end
- 30 Nov 2032
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Nucresiran
- Sterile Normal Saline (0.9% NaCl)
- Record updated
- 20 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with transthyretin amyloidosis (ATTR) with heart disease, who have had heart failure. It compares nucresiran with placebo.
- Age
- 18 to 85 years
- Sex
- All sexes
- Disease stage
- ATTR amyloidosis with cardiomyopathy, hereditary or wild-type. History of heart failure with at least 1 hospital stay for it, or symptoms that need a diuretic.
- Earlier treatment
- Can be taking approved TTR stabilizers (for example tafamidis, acoramidis) and heart failure treatment. Cannot have had, or be getting, TTR-lowering therapy.
- Biomarker or test result
- NT-proBNP above 300 ng/L and below 8500 ng/L. With permanent or persistent atrial fibrillation: above 600 ng/L and below 8500 ng/L.
Main reasons for not taking part
- NYHA Class IV heart failure
- NYHA Class III heart failure together with ATTR Amyloidosis Disease Stage 3
- Polyneuropathy disability (PND) score IIIa, IIIb, or IV
- eGFR below 30 mL/min/1.73m^2 at screening
- Past or current TTR-lowering therapy
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Has received prior or currently receiving TTR-lowering therapy
- Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3
- Has an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m\^2 at screening
- Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in Austria
Also in 35 other countries, 238 sites
- A.O. Krankenhaus St. Josef Braunau GmbHBraunau Am Inn, AustriaTaking people
- Medical University of GrazGraz, AustriaTaking people
- Klinik FavoritenVienna, AustriaTaking people
- Medical University of ViennaVienna, AustriaTaking people
- Stadt Wien Wiener GesundheitsverbundVienna, AustriaTaking people
- Klinikum Wels-Grieskirchen GmbHWels, AustriaTaking people
About the trial
What the trial wants to find out
The purpose of this study is to:
Read full original descriptionShow less
* 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
The 2 groups in the trial
- PlaceboPlacebo, for comparison
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.
Treatment: Nucresiran and Sterile Normal Saline (0.9% NaCl)
- Nucresiran 300 mgTreatment being tested
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.
Treatment: Nucresiran
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Tests nucresiran against placebo in people with transthyretin amyloidosis heart diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07052903, who can take part
- Record updated
- 20 October 2026