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MAGNITUDE: A Study of NTLA-2001 for Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)

This study, called MAGNITUDE, is testing a single dose of NTLA-2001 compared to a placebo (an inactive substance) in people with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). ATTR-CM is a condition where abnormal proteins build up in the heart, causing heart failure. You might be able to join if you are 18 to 90 years old, have a confirmed diagnosis of ATTR-CM, and have heart failure symptoms that are stable. Your NT-proBNP (a blood marker for heart failure) must also be within a specific range. The study aims to see if NTLA-2001 can reduce the risk of death from heart problems and other heart-related events. The current recruitment status is unclear.

Study design
This is a multinational, multicenter, double-blind, placebo-controlled study involving about 1200 participants. Participants will be randomly assigned to receive either NTLA-2001 or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a maximum of 18 months to approximately 5 years, depending on event rates, to measure cardiovascular mortality and events.

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NCT06128629

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

Recruiting
PHASE3Ages 18–90InterventionalTreatment
Intellia Therapeutics
~1,200 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:NTLA-2001Placebo

At a glance

Recruiting sites
120 of 132 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite outcome of cardiovascular (CV) mortality and CV events
Measured over Maximum study duration is dependent on event rates and is estimated to be at least 18 months and up to approximately 5 years

Conditions

Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Explore related trials

ATTR Amyloidosis

Where it's being run

132 sites across 56 states
Brazil9
Italy7
United Kingdom7
Argentina6
Spain6
Texas5
Belgium5
France5

Who to contact

Trial Manager at Intellia
[email protected]
1-857-285-6200 · ext. 6
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Composite outcome of cardiovascular (CV) mortality and CV eventsMaximum study duration is dependent on event rates and is estimated to be at least 18 months and up to approximately 5 years