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

March 23, 2026 updated by: Intellia Therapeutics

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multinational, multicenter, double-blind, placebo-controlled study in approximately 1200 participants, who will be randomized to receive a single infusion of either NTLA-2001 or placebo.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina
        • Recruiting
        • Fundacion Favalro
      • Buenos Aires, Argentina
        • Recruiting
        • ICBA
      • Ciudad Autonoma de Buenos Aire, Argentina
        • Recruiting
        • Hospital Italiano de Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Argentina
        • Recruiting
        • Fundacion Favaloro
      • Rosario, Argentina
        • Recruiting
        • Hospital Privado de Rosario
  • Australia
      • Adelaide, Australia
        • Recruiting
        • Royal Adelaide Hospital
      • Melbourne, Australia
        • Recruiting
        • The Alfred Hospital
      • Woolloongabba, Australia
        • Recruiting
        • Princess Alexandra Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
        • Recruiting
        • The Canberra Hospital
    • New South Wales
      • Westmead, New South Wales, Australia
        • Recruiting
        • Westmead Hospital
    • Queensland
      • Cairns, Queensland, Australia
        • Withdrawn
        • Cairns Hospital
    • Victoria
      • Box Hill, Victoria, Australia
        • Recruiting
        • Eastern Health - Box Hill Hospital
    • Western Australia
      • Perth, Western Australia, Australia
        • Recruiting
        • Fiona Stanley Hospital
  • Austria
      • Innsbruck, Austria
        • Recruiting
        • Medizinische Universitaet Innsbruck
      • Sankt Pölten, Austria
        • Recruiting
        • Universitaesklinikum St. Poelten
  • Belgium
      • Bruges, Belgium
        • Recruiting
        • AZ Sint-Jan Brugge
      • Brussels, Belgium
        • Recruiting
        • Universite Libre de Bruxelles (ULB) - Hopital Erasme
      • Edegem, Belgium
        • Recruiting
        • Antwerp University Hospital
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
      • Liège, Belgium
        • Recruiting
        • Centre Hospitalier Régional de la Citadelle
  • Brazil
      • Belo Horizonte, Brazil
        • Recruiting
        • Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte
      • Niterói, Brazil
        • Recruiting
        • Complexo Hospitalar de Niterói (CHN-DASA)
      • Ribeirão Preto, Brazil
        • Recruiting
        • HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
      • Ribeirão Preto, Brazil
        • Recruiting
        • CAPED - Centro Avancado de Pesquisa
      • Salvador, Brazil
        • Recruiting
        • Cardiopulmonar da Bahia S. A. (Hospital Cardio Pulmonar)
      • São Paulo, Brazil
        • Recruiting
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil
        • Recruiting
        • Hospital israelita Albert Einstein
      • São Paulo, Brazil
        • Recruiting
        • PSEG Centro de Pesquisa Clinica S.A.
      • São Paulo, Brazil
        • Recruiting
        • Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Alberta Health Services - University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Vancouver Coastal Health Research Institute
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • University Health Network - Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • McGill University Health Centre
  • Czechia
      • Brno, Czechia
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • Recruiting
        • Rigshospitalet
  • France
      • Créteil, France
        • Recruiting
        • AP-HP Hopital Henri Mondor
      • Marseille, France
        • Recruiting
        • AP-HM - Hopital de la Timone
      • Paris, France
        • Recruiting
        • AP-HP Hopital Bichat - Claude Bernard
      • Rennes, France
        • Recruiting
        • CHU Rennes - Hôpital Pontchaillou
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse - Hopital Rangueil
  • Germany
      • Berlin, Germany
        • Recruiting
        • Charite Universitaetsmedizin Berlin
      • Essen, Germany
        • Recruiting
        • Universitaetsklinikum Essen
      • Heidelberg, Germany
        • Recruiting
        • Universitaetsklinikum Heidelberg
      • Würzburg, Germany
        • Recruiting
        • Universitaetsklinikum Wuerzburg
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Health Care Campus
      • Jerusalem, Israel
        • Recruiting
        • Hadassah University Hospital, Ein Karem
      • Tel Litwinsky, Israel
        • Recruiting
        • Sheba medical center
  • Italy
      • Bologna, Italy
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
      • Cona, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi
      • Genova, Italy
        • Recruiting
        • Ospedale Policlinico San Martino IRCCS
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
      • Pisa, Italy
        • Recruiting
        • Fondazione Toscana Gabriele Monasterio per la Ricerca Medica
      • Trieste, Italy
        • Recruiting
        • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
  • Japan
      • Kumamoto, Japan
        • Recruiting
        • Kumamoto University Hospital
      • Osaka, Japan
        • Recruiting
        • National Cerebral and Cardiovascular Center
      • Tokyo, Japan
        • Recruiting
        • The University of Tokyo Hospital
      • Toyama, Japan
        • Recruiting
        • Toyama University Hospital
  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Netherlands
      • Groningen, Netherlands
        • Recruiting
        • University Medical Center
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC
      • Utrecht, Netherlands
        • Recruiting
        • Universitair Medisch Centrum Utrecht
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • New Zealand Clinical Research
      • Christchurch, New Zealand
        • Recruiting
        • New Zealand Clinical Research
  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital - Rikshospitalet
  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Centro Hospitalar Universitário de Lisboa Norte
      • Porto, Portugal
        • Recruiting
        • Centro Hospitalar Universitario do Porto
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital
      • Singapore, Singapore
        • Recruiting
        • National Heart Centre
  • South Korea
      • Gwangju, South Korea
        • Withdrawn
        • Chonnam National University Hospital
      • Seoul, South Korea
        • Withdrawn
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Withdrawn
        • Samsung Medical Center
      • Seoul, South Korea
        • Withdrawn
        • Seoul National University Hospital
  • Spain
      • A Coruña, Spain
        • Recruiting
        • Hospital Universitario de A Coruña
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari de Bellvitge
      • Majadahonda, Spain
        • Recruiting
        • Hospital Universitario Puerta De Hierro
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Palma de Mallorca, Spain
        • Recruiting
        • Hospital Universitario Son Llàtzer
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
      • Umeå, Sweden
        • Recruiting
        • University Hospital of Umeå
  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Recruiting
        • Taipai Veterans General Hospital
  • United Kingdom
      • Birmingham, United Kingdom
        • Active, not recruiting
        • Synexus Midlands Clinical Research Centre
      • Cardiff, United Kingdom
        • Active, not recruiting
        • Synexus Wales Clinical Research Centre
      • Glasgow, United Kingdom
        • Active, not recruiting
        • Synexus Scotland Clinical Research Centre
      • Hexham, United Kingdom
        • Active, not recruiting
        • Synexus Hexham Clinical Research Centre
      • Liverpool, United Kingdom
        • Active, not recruiting
        • Synexus Merseyside Clinical Research Centre
      • London, United Kingdom
        • Recruiting
        • Richmond Pharmacology
      • Manchester, United Kingdom
        • Active, not recruiting
        • Synexus Manchester Clinical Research Centre
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90073
        • Recruiting
        • Western Greater Los Angeles VA Medical Center
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University
      • San Diego, California, United States, 92103
        • Recruiting
        • University of California, San Diego (UCSD) - Medical Center
    • Colorado
      • Denver, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School Of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center - MedStar Heart and Vascular Institute
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic - Jacksonville
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Gill Heart Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Withdrawn
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • St. Luke's Hospital
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • Recruiting
        • New York University (NYU) School of Medicine - Langone Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Ohio Health Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University (OHSU)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15219
        • Recruiting
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75201
        • Recruiting
        • Baylor Scott & White Research Institute
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott and White - The Heart Hospital Baylor Plano
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • INOVA Fairfax Hospital
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University - Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • New York Heart Association (NYHA) Class IV HF
  • Polyneuropathy Disability score of IV (confined to wheelchair or bed)
  • Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
  • 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
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2
  • History of liver disease
  • Uncontrolled blood pressure
  • Unable or unwilling to take vitamin A supplementation for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NTLA-2001
Single intravenous (IV) infusion of NTLA-2001
Biological: NTLA-2001
NTLA-2001 (55mg) by IV infusion
Placebo Comparator: Placebo
Single IV infusion of normal saline
Drug: Placebo
Normal saline (0.9% NaCl) by IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite outcome of cardiovascular (CV) mortality and CV events
Time Frame: Maximum study duration is dependent on event rates and is estimated to be at least 18 months and up to approximately 5 years
Maximum study duration is dependent on event rates and is estimated to be at least 18 months and up to approximately 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in baseline to month 18 in serum TTR
Time Frame: Baseline, Month 18
Baseline, Month 18
Change from baseline to month 18 in KCCQ-OS score
Time Frame: Baseline, Month 18
Baseline, Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intellia Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITL-2001-CL-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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