Actively Recruiting

Phase 3
Age: 18Years - 90Years
All Genders
NCT06128629

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

Led by Intellia Therapeutics · Updated on 2026-03-27

1200

Participants Needed

132

Research Sites

224 weeks

Total Duration

On this page

Sponsors

I

Intellia Therapeutics

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented diagnosis of ATTR amyloidosis with cardiomyopathy
  • Medical history of heart failure
  • Heart failure symptoms are optimally managed and clinically stable within 28 days before study treatment
  • Screening NT-proBNP blood level between 600 and 10,000 pg/mL
Not Eligible

You will not qualify if you...

  • New York Heart Association Class IV heart failure
  • Polyneuropathy Disability score of IV (confined to wheelchair or bed)
  • Infection with hepatitis B, hepatitis C, or HIV
  • Active malignancy within 3 years before screening
  • RNA silencer therapy within 12 months before dosing, including patisiran, inotersen, eplontersen; any prior use of vutrisiran is not allowed
  • Starting tafamidis or acoramidis within 56 days before dosing
  • Estimated glomerular filtration rate less than 30 mL/min/1.73m^2
  • History of liver disease
  • Uncontrolled blood pressure
  • Unable or unwilling to take vitamin A supplements during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 132 locations

1

University of Arizona

Tucson, Arizona, United States, 85724

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

Western Greater Los Angeles VA Medical Center

Los Angeles, California, United States, 90073

Actively Recruiting

4

Stanford University

Palo Alto, California, United States, 94305

Actively Recruiting

5

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

San Diego, California, United States, 92103

Actively Recruiting

6

University of Colorado Denver

Denver, Colorado, United States, 80045

Actively Recruiting

7

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

Actively Recruiting

8

MedStar Washington Hospital Center - MedStar Heart and Vascular Institute

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

9

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States, 32224

Actively Recruiting

10

Cleveland Clinic of Florida

Weston, Florida, United States, 33331

Actively Recruiting

11

Emory University School of Medicine

Atlanta, Georgia, United States, 30322

Actively Recruiting

12

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

13

Indiana University Health

Indianapolis, Indiana, United States, 46202

Actively Recruiting

14

University of Kentucky Gill Heart Institute

Lexington, Kentucky, United States, 40536

Actively Recruiting

15

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

16

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

17

Boston University School of Medicine

Boston, Massachusetts, United States, 02118

Actively Recruiting

18

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

19

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Withdrawn

20

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

21

St. Luke's Hospital

Kansas City, Missouri, United States, 64111

Actively Recruiting

22

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

New York, New York, United States, 10016

Actively Recruiting

23

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

24

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

25

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

26

Ohio Health Research Institute

Columbus, Ohio, United States, 43214

Actively Recruiting

27

Oregon Health and Science University (OHSU)

Portland, Oregon, United States, 97239

Actively Recruiting

28

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

29

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

30

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15219

Actively Recruiting

31

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

32

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75201

Actively Recruiting

33

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

34

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

35

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

36

Baylor Scott and White - The Heart Hospital Baylor Plano

Plano, Texas, United States, 75093

Actively Recruiting

37

INOVA Fairfax Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

38

Virginia Commonwealth University - Department of Internal Medicine

Richmond, Virginia, United States, 23298

Actively Recruiting

39

Fundacion Favalro

Buenos Aires, Argentina

Actively Recruiting

40

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Actively Recruiting

41

ICBA

Buenos Aires, Argentina

Actively Recruiting

42

Fundacion Favaloro

Ciudad Autonoma de Buenos Aire, Argentina

Actively Recruiting

43

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aire, Argentina

Actively Recruiting

44

Hospital Privado de Rosario

Rosario, Argentina

Actively Recruiting

45

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Actively Recruiting

46

Westmead Hospital

Westmead, New South Wales, Australia

Actively Recruiting

47

Cairns Hospital

Cairns, Queensland, Australia

Withdrawn

48

Eastern Health - Box Hill Hospital

Box Hill, Victoria, Australia

Actively Recruiting

49

Fiona Stanley Hospital

Perth, Western Australia, Australia

Actively Recruiting

50

Royal Adelaide Hospital

Adelaide, Australia

Actively Recruiting

51

The Alfred Hospital

Melbourne, Australia

Actively Recruiting

52

Princess Alexandra Hospital

Woolloongabba, Australia

Actively Recruiting

53

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Actively Recruiting

54

Universitaesklinikum St. Poelten

Sankt Pölten, Austria

Actively Recruiting

55

AZ Sint-Jan Brugge

Bruges, Belgium

Actively Recruiting

56

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Brussels, Belgium

Actively Recruiting

57

Antwerp University Hospital

Edegem, Belgium

Actively Recruiting

58

UZ Leuven

Leuven, Belgium

Actively Recruiting

59

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Actively Recruiting

60

Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte

Belo Horizonte, Brazil

Actively Recruiting

61

Complexo Hospitalar de Niterói (CHN-DASA)

Niterói, Brazil

Actively Recruiting

62

CAPED - Centro Avancado de Pesquisa

Ribeirão Preto, Brazil

Actively Recruiting

63

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

Ribeirão Preto, Brazil

Actively Recruiting

64

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

Salvador, Brazil

Actively Recruiting

65

Hospital Israelita Albert Einstein

São Paulo, Brazil

Actively Recruiting

66

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Actively Recruiting

67

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

São Paulo, Brazil

Actively Recruiting

68

PSEG Centro de Pesquisa Clinica S.A.

São Paulo, Brazil

Actively Recruiting

69

Alberta Health Services - University of Calgary

Calgary, Alberta, Canada

Actively Recruiting

70

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

Actively Recruiting

71

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Actively Recruiting

72

McGill University Health Centre

Montreal, Quebec, Canada

Actively Recruiting

73

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Actively Recruiting

74

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

75

Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

76

AP-HP Hopital Henri Mondor

Créteil, France

Actively Recruiting

77

AP-HM - Hopital de la Timone

Marseille, France

Actively Recruiting

78

AP-HP Hopital Bichat - Claude Bernard

Paris, France

Actively Recruiting

79

CHU Rennes - Hopital Pontchaillou

Rennes, France

Actively Recruiting

80

CHU de Toulouse - Hopital Rangueil

Toulouse, France

Actively Recruiting

81

Charite Universitaetsmedizin Berlin

Berlin, Germany

Actively Recruiting

82

Universitaetsklinikum Essen

Essen, Germany

Actively Recruiting

83

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Actively Recruiting

84

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Actively Recruiting

85

Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika

Budapest, Hungary

Actively Recruiting

86

Rambam Health Care Campus

Haifa, Israel

Actively Recruiting

87

Hadassah University Hospital, Ein Karem

Jerusalem, Israel

Actively Recruiting

88

Sheba Medical Center

Tel Litwinsky, Israel

Actively Recruiting

89

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

Bologna, Italy

Actively Recruiting

90

Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna

Cona, Italy

Actively Recruiting

91

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Actively Recruiting

92

Ospedale Policlinico San Martino IRCCS

Genova, Italy

Actively Recruiting

93

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Actively Recruiting

94

Fondazione Toscana Gabriele Monasterio per la Ricerca Medica

Pisa, Italy

Actively Recruiting

95

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

Trieste, Italy

Actively Recruiting

96

Kumamoto University Hospital

Kumamoto, Japan

Actively Recruiting

97

National Cerebral and Cardiovascular Center

Osaka, Japan

Actively Recruiting

98

The University of Tokyo Hospital

Tokyo, Japan

Actively Recruiting

99

Toyama University Hospital

Toyama, Japan

Actively Recruiting

100

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

Actively Recruiting

101

University Medical Center

Groningen, Netherlands

Actively Recruiting

102

Erasmus MC

Rotterdam, Netherlands

Actively Recruiting

103

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Actively Recruiting

104

New Zealand Clinical Research

Auckland, New Zealand

Actively Recruiting

105

New Zealand Clinical Research

Christchurch, New Zealand

Actively Recruiting

106

Oslo University Hospital - Rikshospitalet

Oslo, Norway

Actively Recruiting

107

Centro Hospitalar Universitario de Lisboa Norte

Lisbon, Portugal

Actively Recruiting

108

Centro Hospitalar Universitario do Porto

Porto, Portugal

Actively Recruiting

109

National Heart Centre

Singapore, Singapore

Actively Recruiting

110

National University Hospital

Singapore, Singapore

Actively Recruiting

111

Chonnam National University Hospital

Gwangju, South Korea

Withdrawn

112

Samsung Medical Center

Seoul, South Korea

Withdrawn

113

Seoul National University Hospital

Seoul, South Korea

Withdrawn

114

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Withdrawn

115

Hospital Universitario de A Coruna

A Coruña, Spain

Actively Recruiting

116

Hospital Universitari de Bellvitge

Barcelona, Spain

Actively Recruiting

117

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Actively Recruiting

118

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Actively Recruiting

119

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Actively Recruiting

120

Hospital Universitario Son Llatzer

Palma de Mallorca, Spain

Actively Recruiting

121

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

122

University Hospital of Umea

Umeå, Sweden

Actively Recruiting

123

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Actively Recruiting

124

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

125

Taipai Veterans General Hospital

Taipei, Taiwan

Actively Recruiting

126

Synexus Midlands Clinical Research Centre

Birmingham, United Kingdom

Active, Not Recruiting

127

Synexus Wales Clinical Research Centre

Cardiff, United Kingdom

Active, Not Recruiting

128

Synexus Scotland Clinical Research Centre

Glasgow, United Kingdom

Active, Not Recruiting

129

Synexus Hexham Clinical Research Centre

Hexham, United Kingdom

Active, Not Recruiting

130

Synexus Merseyside Clinical Research Centre

Liverpool, United Kingdom

Active, Not Recruiting

131

Richmond Pharmacology

London, United Kingdom

Actively Recruiting

132

Synexus Manchester Clinical Research Centre

Manchester, United Kingdom

Active, Not Recruiting

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Research Team

T

Trial Manager at Intellia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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