MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Intellia Therapeutics · with Regeneron Pharmaceuticals · NCT06128629
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–90 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 1200
- US sites recruiting
- 37
- Study start
- December 13, 2023
- Record last updated
- March 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
Being studied: NTLA-2001; Placebo
Conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
University of Arizona
Tucson, AZ 85724
Cedars-Sinai Medical Center
Los Angeles, CA 90048
Western Greater Los Angeles VA Medical Center
Los Angeles, CA 90073
Stanford University
Palo Alto, CA 94305
University of California, San Diego (UCSD) - Medical Center
San Diego, CA 92103
University of Colorado Denver
Denver, CO 80045
Yale University School of Medicine
New Haven, CT 06510
MedStar Washington Hospital Center - MedStar Heart and Vascular Institute
Washington D.C., DC 20010
Mayo Clinic - Jacksonville
Jacksonville, FL 32224
Cleveland Clinic of Florida
Weston, FL 33331
Emory University School of Medicine
Atlanta, GA 30322
Northwestern University
Chicago, IL 60611
Indiana University Health
Indianapolis, IN 46202
University of Kentucky Gill Heart Institute
Lexington, KY 40536
Johns Hopkins University
Baltimore, MD 21287
Brigham and Women's Hospital
Boston, MA 02115
Boston University School of Medicine
Boston, MA 02118
University of Michigan
Ann Arbor, MI 48109
Mayo Clinic
Rochester, MN 55905
St. Luke's Hospital
Kansas City, MO 64111
New York University (NYU) School of Medicine - Langone Medical Center
New York, NY 10016
Columbia University Medical Center
New York, NY 10032
Duke University Medical Center
Durham, NC 27710
Cleveland Clinic
Cleveland, OH 44195
Ohio Health Research Institute
Columbus, OH 43214
Oregon Health and Science University (OHSU)
Portland, OR 97239
Penn Presbyterian Medical Center
Philadelphia, PA 19104
Allegheny General Hospital
Pittsburgh, PA 15212
University of Pittsburgh Medical Center
Pittsburgh, PA 15219
Medical University of South Carolina
Charleston, SC 29425
Baylor Scott & White Research Institute
Dallas, TX 75201
University of Texas Southwestern Medical Center
Dallas, TX 75390
Baylor College of Medicine
Houston, TX 77030
Houston Methodist Hospital
Houston, TX 77030
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, TX 75093
INOVA Fairfax Hospital
Falls Church, VA 22042
Virginia Commonwealth University - Department of Internal Medicine
Richmond, VA 23298
Study contacts (from the official record)
- Trial Manager at Intellia · 1-857-285-6200 · medicalinformation@intelliatx.com
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