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New treatment option for Transthyretin Amyloidosis With Cardiomyopathy
Official title TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
ClinicalTrials.gov ID: NCT07052903
What this study is testing
What is Nucresiran?
Nucresiran is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for transthyretin amyloidosis with cardiomyopathy.
Also referred to as ALN-TTRSC04.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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 \ 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...
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Stanford, California, United States
- Norwich, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Brandon, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Gainesville, Georgia, United States
- Tucker, Georgia, United States
- Evanston, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Manhasset, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
+ 182 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Stanford, California, United States; Norwich, Connecticut, United States; Washington D.C., District of Columbia, United States; Brandon, Florida, United States; Miami, Florida, United States and 196 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.