MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Trial ID or NCT#
NCT06128629
Status
RECRUITING
Purpose
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
Official Title
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)
Eligibility Criteria
Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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* Liver failure* Uncontrolled blood pressure* Unable or unwilling to take vitamin A supplementation for the duration of the study
Investigator(s)
Kevin M. Alexander, MD, FACC, FHFSA
Heart failure cardiologist
Assistant Professor of Medicine (Cardiovascular Medicine)
Contact us to find out if this trial is right for you.
Contact
Trial Manager at Intellia
1-857-285-6200
View on ClinicalTrials.gov
