RecruitingPhase 3NCT06128629

MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)

MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)

Sponsor

Intellia Therapeutics

Enrollment

1,200 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Summary

To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called NTLA-2001 and a drug called Placebo for people with transthyretin amyloidosis (attr) with cardiomyopathy. The study is currently recruiting participants at 132 locations. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNTLA-2001

NTLA-2001 (55mg) by IV infusion

DRUGPlacebo

Normal saline (0.9% NaCl) by IV infusion

Locations(132)

University of Arizona

Tucson, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Western Greater Los Angeles VA Medical Center

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

University of California, San Diego (UCSD) - Medical Center

San Diego, California, United States

University of Colorado Denver

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

MedStar Washington Hospital Center - MedStar Heart and Vascular Institute

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

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Cleveland Clinic of Florida

Weston, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Kentucky Gill Heart Institute

Lexington, Kentucky, United States

Johns Hopkins University

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston University School of Medicine

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Luke's Hospital

Kansas City, Missouri, United States

New York University (NYU) School of Medicine - Langone Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Oregon Health and Science University (OHSU)

Portland, Oregon, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Baylor Scott and White - The Heart Hospital Baylor Plano

Plano, Texas, United States

INOVA Fairfax Hospital

Falls Church, Virginia, United States

Virginia Commonwealth University - Department of Internal Medicine

Richmond, Virginia, United States

Fundacion Favalro

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

ICBA

Buenos Aires, Argentina

Fundacion Favaloro

Ciudad Autonoma de Buenos Aire, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aire, Argentina

Hospital Privado de Rosario

Rosario, Argentina

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Cairns Hospital

Cairns, Queensland, Australia

Eastern Health - Box Hill Hospital

Box Hill, Victoria, Australia

Fiona Stanley Hospital

Perth, Western Australia, Australia

Royal Adelaide Hospital

Adelaide, Australia

The Alfred Hospital

Melbourne, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Universitaesklinikum St. Poelten

Sankt Pölten, Austria

AZ Sint-Jan Brugge

Bruges, Belgium

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte

Belo Horizonte, Brazil

Complexo Hospitalar de Niterói (CHN-DASA)

Niterói, Brazil

CAPED - Centro Avancado de Pesquisa

Ribeirão Preto, Brazil

HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

Ribeirão Preto, Brazil

Cardiopulmonar da Bahia S. A. (Hospital Cardio Pulmonar)

Salvador, Brazil

Hospital Israelita Albert Einstein

São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP

São Paulo, Brazil

PSEG Centro de Pesquisa Clinica S.A.

São Paulo, Brazil

Alberta Health Services - University of Calgary

Calgary, Alberta, Canada

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

AP-HP Hopital Henri Mondor

Créteil, France

AP-HM - Hopital de la Timone

Marseille, France

AP-HP Hopital Bichat - Claude Bernard

Paris, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

CHU de Toulouse - Hopital Rangueil

Toulouse, France

Charite Universitaetsmedizin Berlin

Berlin, Germany

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika

Budapest, Hungary

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospital, Ein Karem

Jerusalem, Israel

Sheba Medical Center

Tel Litwinsky, Israel

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

Bologna, Italy

Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna

Cona, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Toscana Gabriele Monasterio per la Ricerca Medica

Pisa, Italy

Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara

Trieste, Italy

Kumamoto University Hospital

Kumamoto, Japan

National Cerebral and Cardiovascular Center

Osaka, Japan

The University of Tokyo Hospital

Tokyo, Japan

Toyama University Hospital

Toyama, Japan

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

University Medical Center

Groningen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

New Zealand Clinical Research

Auckland, New Zealand

New Zealand Clinical Research

Christchurch, New Zealand

Oslo University Hospital - Rikshospitalet

Oslo, Norway

Centro Hospitalar Universitario de Lisboa Norte

Lisbon, Portugal

Centro Hospitalar Universitario do Porto

Porto, Portugal

National Heart Centre

Singapore, Singapore

National University Hospital

Singapore, Singapore

Chonnam National University Hospital

Gwangju, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Universitario de A Coruna

A Coruña, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Son Llatzer

Palma de Mallorca, Spain

Karolinska University Hospital

Stockholm, Sweden

University Hospital of Umea

Umeå, Sweden

Far Eastern Memorial Hospital

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipai Veterans General Hospital

Taipei, Taiwan

Synexus Midlands Clinical Research Centre

Birmingham, United Kingdom

Synexus Wales Clinical Research Centre

Cardiff, United Kingdom

Synexus Scotland Clinical Research Centre

Glasgow, United Kingdom

Synexus Hexham Clinical Research Centre

Hexham, United Kingdom

Synexus Merseyside Clinical Research Centre

Liverpool, United Kingdom

Richmond Pharmacology

London, United Kingdom

Synexus Manchester Clinical Research Centre

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06128629