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RECRUITING
NCT07052903
PHASE3

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Sponsor: Alnylam Pharmaceuticals

View on ClinicalTrials.gov

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

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)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1250

Start Date

2025-07-02

Completion Date

2032-11-30

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Nucresiran

Nucresiran 300 mg administered SC q6M

DRUG

Sterile Normal Saline (0.9% NaCl)

Sterile Normal Saline (0.9% NaCl) administered SC once q6M

Locations (157)

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La Jolla, California, United States

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Washington D.C., District of Columbia, United States

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Brandon, Florida, United States

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Atlanta, Georgia, United States

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Gainesville, Georgia, United States

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Tucker, Georgia, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Manhasset, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Rosario, Argentina

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Bedford Park, Australia

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Box Hill, Australia

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Chermside, Australia

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Darlinghurst, Australia

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Joondalup, Australia

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Braunau am Inn, Austria

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Graz, Austria

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Wels, Austria

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Aalst, Belgium

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Brussels, Belgium

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Dendermonde, Belgium

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Ghent, Belgium

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Hasselt, Belgium

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Leuven, Belgium

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Liège, Belgium

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Roeselare, Belgium

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Belo Horizonte, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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São Paulo, Brazil

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London, Canada

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Aarhus N, Denmark

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København Ø, Denmark

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Odense C, Denmark

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Chambray-lès-Tours, France

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La Tronche, France

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Marseille, France

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Montpellier, France

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Paris, France

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Pessac, France

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Reims, France

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Rennes, France

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Rouen, France

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Saint-Herblain, France

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Toulouse, France

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Berlin, Germany

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Hanover, Germany

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Leipzig, Germany

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Munich, Germany

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Münster, Germany

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Würzburg, Germany

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Athens, Greece

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Athens, Greece

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Heraklion, Greece

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Thessaloniki, Greece

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Hong Kong, Hong Kong

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Be’er Ya‘aqov, Israel

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Haifa, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Ancona, Italy

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Brescia, Italy

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Florence, Italy

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Forlì, Italy

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Naples, Italy

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Pavia, Italy

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Pisa, Italy

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Rimini, Italy

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Roma, Italy

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Bunkyō City, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Kagawa, Japan

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Kashihara, Japan

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Kobe, Japan

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Kumamoto, Japan

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Kurume, Japan

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Matsumoto-shi, Japan

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Nankoku, Japan

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Niigata, Japan

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Okayama, Japan

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Sapporo, Japan

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Sapporo, Japan

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Sendai, Japan

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Kajang, Malaysia

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Eindhoven, Netherlands

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Groningen, Netherlands

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Rotterdam, Netherlands

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Utrecht, Netherlands

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Christchurch, New Zealand

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Hamilton, New Zealand

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Carnaxide, Portugal

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Creixomil, Portugal

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Leiria, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Vila Real, Portugal

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Viseu, Portugal

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Incheon, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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A Coruña, Spain

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Barcelona, Spain

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Barcelona, Spain

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Bilbao, Spain

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El Palmar, Spain

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Huelva, Spain

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Jaén, Spain

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L'Hospitalet de Llobregat, Spain

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Lleida, Spain

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Madrid, Spain

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Madrid, Spain

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Palma de Mallorca, Spain

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Pamplona, Spain

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Salamanca, Spain

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Santiago de Compostela, Spain

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Valencia, Spain

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Valencia, Spain

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Vigo, Spain

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Gothenburg, Sweden

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Lund, Sweden

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Solna, Sweden

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Basel, Switzerland

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Genève, Switzerland

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Lucerne, Switzerland

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Sankt Gallen, Switzerland

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New Taipei City, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Bellshill, United Kingdom

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Birmingham, United Kingdom

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Cardiff, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom