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RecruitingPhase 3

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

Intellia Therapeutics · with Regeneron Pharmaceuticals · NCT06128629

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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

Study contacts (from the official record)

  • Trial Manager at Intellia · 1-857-285-6200 · medicalinformation@intelliatx.com
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With… (NCT06128629) | Bored Studies