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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Intellia Therapeutics
Study ID
NCT06128629
Phase
PHASE3
Status
Recruiting
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Conditions

  • Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • NTLA-2001 — BIOLOGICAL
    NTLA-2001 (55mg) by IV infusion
  • Placebo — DRUG
    Normal saline (0.9% NaCl) by IV infusion

Study Details

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

Key Dates

Start date
Dec 13, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NTLA-2001
    Single intravenous (IV) infusion of NTLA-2001
  • Placebo Comparator: Placebo
    Single IV infusion of normal saline

Primary Outcome Measure

Composite outcome of cardiovascular (CV) mortality and CV events [ Time Frame: Maximum study duration is dependent on event rates and is estimated to be at least 18 months and up to approximately 5 years ]

Central Contacts

Locations (38)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Western Greater Los Angeles VA Medical CenterLos AngelesCalifornia90073-
Stanford UniversityPalo AltoCalifornia94305-
University of California, San Diego (UCSD) - Medical CenterSan DiegoCalifornia92103-
University of Colorado DenverDenverColorado80045-
Yale University School of MedicineNew HavenConnecticut06510-
MedStar Washington Hospital Center - MedStar Heart and Vascular InstituteWashington D.C.District of Columbia20010-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Cleveland Clinic of FloridaWestonFlorida33331-
Emory University School of MedicineAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Indiana University HealthIndianapolisIndiana46202-
University of Kentucky Gill Heart InstituteLexingtonKentucky40536-
Johns Hopkins UniversityBaltimoreMaryland21287-
Boston University School of MedicineBostonMassachusetts02118-
Brigham and Women's HospitalBostonMassachusetts02115-
University of MichiganAnn ArborMichigan48109-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Mayo ClinicRochesterMinnesota55905-
St. Luke's HospitalKansas CityMissouri64111-
Columbia University Medical CenterNew YorkNew York10032-
New York University (NYU) School of Medicine - Langone Medical CenterNew YorkNew York10016-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Ohio Health Research InstituteColumbusOhio43214-
Oregon Health and Science University (OHSU)PortlandOregon97239-
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
University of Pittsburgh Medical CenterPittsburghPennsylvania15219-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Baylor Scott & White Research InstituteDallasTexas75201-
University of Texas Southwestern Medical CenterDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-
Houston Methodist HospitalHoustonTexas77030-
Baylor Scott and White - The Heart Hospital Baylor PlanoPlanoTexas75093-
INOVA Fairfax HospitalFalls ChurchVirginia22042-
Virginia Commonwealth University - Department of Internal MedicineRichmondVirginia23298-

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZCedars-Sinai Medical Center· Los Angeles, CAWestern Greater Los Angeles VA Medical Center· Los Angeles, CAStanford University· Palo Alto, CAUniversity of California, San Diego (UCSD) - Medical Center· San Diego, CAUniversity of Colorado Denver· Denver, CO

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