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

RecruitingPhase 3

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)

Who can join

Ages 18 to 90 · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Intellia Therapeutics · Participants: 1,200 · Started: Dec 13, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06128629

Locations in the U.S.

ArizonaUniversity of Arizona, Tucson
CaliforniaCedars-Sinai Medical Center, Los Angeles
Western Greater Los Angeles VA Medical Center, Los Angeles
Stanford University, Palo Alto
University of California, San Diego (UCSD) - Medical Center, San Diego
ColoradoUniversity of Colorado Denver, Denver
ConnecticutYale University School of Medicine, New Haven
District of ColumbiaMedStar Washington Hospital Center - MedStar Heart and Vascular Institute, Washington D.C.
FloridaMayo Clinic - Jacksonville, Jacksonville
Cleveland Clinic of Florida, Weston
GeorgiaEmory University School of Medicine, Atlanta
IllinoisNorthwestern University, Chicago
IndianaIndiana University Health, Indianapolis
KentuckyUniversity of Kentucky Gill Heart Institute, Lexington
MarylandJohns Hopkins University, Baltimore
MassachusettsBoston University School of Medicine, Boston
Brigham and Women's Hospital, Boston
MichiganUniversity of Michigan, Ann Arbor
MinnesotaMayo Clinic, Rochester
MissouriSt. Luke's Hospital, Kansas City
New YorkColumbia University Medical Center, New York
New York University (NYU) School of Medicine - Langone Medical Center, New York
North CarolinaDuke University Medical Center, Durham
OhioCleveland Clinic, Cleveland
Ohio Health Research Institute, Columbus
OregonOregon Health and Science University (OHSU), Portland
PennsylvaniaPenn Presbyterian Medical Center, Philadelphia
Allegheny General Hospital, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
TexasBaylor Scott & White Research Institute, Dallas
University of Texas Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
Houston Methodist Hospital, Houston
Baylor Scott and White - The Heart Hospital Baylor Plano, Plano
VirginiaINOVA Fairfax Hospital, Falls Church
Virginia Commonwealth University - Department of Internal Medicine, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.