NCT06128629RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 8 Nov 2023
- Start date
- 13 Dec 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- Intellia Therapeutics
- Diseases
- Amyloidosis
- NCT number
- NCT06128629
- EU CT number
- 2023-507220-23-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1200
- From 13 Dec 2023 to the primary completion date, Dec 2027
- 143 sites in 27 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of active malignancy within 3 years prior to screening
- RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed
- Initiation of tafamidis or acoramidis within 56 days prior to study dosing
Other illness
- New York Heart Association (NYHA) Class IV HF
- Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- History of liver disease
Lab values
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
Other
- Polyneuropathy Disability score of IV (confined to wheelchair or bed)
- Uncontrolled blood pressure
- Unable or unwilling to take vitamin A supplementation for the duration of the study
Who the study is looking for
- Documented diagnosis of ATTR amyloidosis with cardiomyopathy
- Medical history of heart failure (HF)
- Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention
- Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (143)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| ICBA Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Fundacion Favalro Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Recruiting |
| Fundacion Favaloro Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Recruiting |
| Hospital Privado de Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Eastern Health - Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Cairns Hospital Coordinator of this site? Confirm its status | Cairns | Australia | Withdrawn |
| The Canberra Hospital Coordinator of this site? Confirm its status | Garran | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| UNICAMP Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Complexo Hospitalar de Niterói (CHN-DASA) Coordinator of this site? Confirm its status | Niterói | Brazil | Recruiting |
| HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| CAPED - Centro Avancado de Pesquisa Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| Instituto de Educacao Pesquisa e Gestao em Saude Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Cardiopulmonar da Bahia S.A. (Hospital Cardio Pulmonar) Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Hospital Israelita Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| PSEG Centro de Pesquisa Clinica S.A. Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Instituto Dante Pazzanese de Cardiologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Alberta Health Services - University of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| University Health Network, Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Vancouver Coastal Health Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Synexus Midlands Clinical Research Centre Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Synexus Wales Clinical Research Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Synexus Scotland Clinical Research Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Synexus Hexham Clinical Research Centre Coordinator of this site? Confirm its status | Hexham | United Kingdom | Withdrawn |
| Synexus Merseyside Clinical Research Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Active, not recruiting |
| Richmond Pharmacology Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Synexus Manchester Clinical Research Centre Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Hadassah University Hospital, Ein Karem Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Fondazione Toscana Gabriele Monasterio Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Cattinara Hospital Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| National Cerebral and Cardiovascular Center Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Withdrawn |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Withdrawn |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Withdrawn |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Withdrawn |
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| New Zealand Clinical Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| New Zealand Clinical Research Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Norrlands University Hospital Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
| National Heart Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Far Eastern Memorial Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipai Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Boston University School of Medicine Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Ohio Health Research Institute Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Baylor Scott & White Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Colorado Denver Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Barbara Ann Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Withdrawn |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Falls Church | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| St. Luke's Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kentucky Gill Heart Institute Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Western Greater Los Angeles VA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| New York University (NYU) School of Medicine - Langone Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Penn Presbyterian Medical Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Baylor Scott and White - The Heart Hospital Baylor Plano Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Oregon Health and Science university (OHSU) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Virginia Commonwealth University - Department of Internal Medicine Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of California, San Diego (UCSD) Medical Center Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Withdrawn |
| MedStar Washington Hospital Center - MedStar Heart and Vascular Institute Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Cleveland Clinic of Florida Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
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