Transthyretin Amyloid Cardiomyopathy Clinical Trial

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

Summary

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

View Full Description

Full Description

This is a multinational, multicenter, double-blind, placebo-controlled study in approximately 765 participants, who will be randomized to receive a single infusion of either NTLA-2001 or placebo.

View Eligibility Criteria

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 1000 pg/mL (or greater than or equal to 2000 pg/mL if participant has known atrial fibrillation)

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 within 6 months prior to study dosing
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2
Liver failure
Uncontrolled blood pressure
Unable or unwilling to take vitamin A supplementation for the duration of the study

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

765

Study ID:

NCT06128629

Recruitment Status:

Recruiting

Sponsor:

Intellia Therapeutics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

Western Greater Los Angeles VA Medical Center
Los Angeles California, 90073, United States
Stanford University
Palo Alto California, 94305, United States
MedStar Washington Hospital Center - MedStar Heart and Vascular Institute
Washington District of Columbia, 20010, United States
University of Kentucky Gill Heart Institute
Lexington Kentucky, 40536, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Columbia University Medical Center
New York New York, 10032, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
Eastern Health - Box Hill Hospital
Box Hill Victoria, , Australia
The Canberra Hospital
Garran , , Australia
Fiona Stanley Hospital
Perth , , Australia
Westmead Hospital
Westmead , , Australia
Alberta Health Services - University of Calgary
Calgary Alberta, , Canada
New Zealand Clinical Research
Auckland , , New Zealand
New Zealand Clinical Research
Christchurch , , New Zealand
Synexus Midlands Clinical Research Centre
Birmingham , , United Kingdom
Synexus Wales Clinical Research Centre
Cardiff , , United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow , , United Kingdom
Synexus Hexham Clinical Research Centre
Hexham , , United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool , , United Kingdom
Richmond Pharmacology
London , , United Kingdom
Synexus Manchester Clinical Research Centre
Manchester , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

765

Study ID:

NCT06128629

Recruitment Status:

Recruiting

Sponsor:


Intellia Therapeutics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider