Clinical Trials in the Netherlands / NCT06128629
Recruiting
Phase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
NCT06128629 · tracked via the Priya Life Science Netherlands tracker
Condition(s) studied
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Investigational drug(s) / intervention(s)
NTLA-2001 →Placebo
NTLA-2001: NTLA-2001 (55mg) by IV infusion
Placebo: Normal saline (0.9% NaCl) by IV infusion
Study summary
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
Eligibility
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
Primary outcome measure(s)
- Composite outcome of cardiovascular (CV) mortality and CV events — Maximum study duration is dependent on event rates and is estimated to be at least 18 months and up to approximately 5 years
Trial sites (132)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona | Tucson | Arizona | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| Western Greater Los Angeles VA Medical Center | Los Angeles | California | Recruiting |
| Stanford University | Palo Alto | California | Recruiting |
| University of California, San Diego (UCSD) - Medical Center | San Diego | California | Recruiting |
| University of Colorado Denver | Denver | Colorado | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| MedStar Washington Hospital Center - MedStar Heart and Vascular Institute | Washington D.C. | District of Columbia | Recruiting |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | Recruiting |
| Cleveland Clinic of Florida | Weston | Florida | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| Indiana University Health | Indianapolis | Indiana | Recruiting |
| University of Kentucky Gill Heart Institute | Lexington | Kentucky | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Boston University School of Medicine | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | Withdrawn |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| St. Luke's Hospital | Kansas City | Missouri | Recruiting |
| New York University (NYU) School of Medicine - Langone Medical Center | New York | New York | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Ohio Health Research Institute | Columbus | Ohio | Recruiting |
| Oregon Health and Science University (OHSU) | Portland | Oregon | Recruiting |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | Recruiting |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| Baylor Scott & White Research Institute | Dallas | Texas | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| Baylor College of Medicine | Houston | Texas | Recruiting |
| Houston Methodist Hospital | Houston | Texas | Recruiting |
| Baylor Scott and White - The Heart Hospital Baylor Plano | Plano | Texas | Recruiting |
| INOVA Fairfax Hospital | Falls Church | Virginia | Recruiting |
| Virginia Commonwealth University - Department of Internal Medicine | Richmond | Virginia | Recruiting |
| Fundacion Favalro | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | Recruiting |
+ 92 more sites — see the full list on the official registry below.
More Intellia Therapeutics trials in the Netherlands
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Active, not recruiting
Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
Enrolling by invitation
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06128629 on ClinicalTrials.gov ↗ ← All trials in the Netherlands