CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 1,200 target
Drug / intervention
NTLA-2001 +1 morebiological
Likely dose
NTLA-2001 55mgfrom record
Key inclusion· 4
  • ✓Documented diagnosis of ATTR amyloidosis with cardiomyopathy
  • ✓Medical history of heart failure
  • ✓HF symptoms optimally managed and clinically stable within 28 days prior to study intervention
  • ✓NT-proBNP between 600 and 10,000 pg/mL at screening
Key exclusion· 10
  • ✕NYHA Class IV heart failure
  • ✕Polyneuropathy Disability score of IV (wheelchair or bed-confined)
  • ✕Hepatitis B, hepatitis C, or HIV infection
  • ✕History of active malignancy within 3 years prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06128629
NCT06128629Phase 3RecruitingHigh MomentumUpdated 3mo ago
CompareCT.gov

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)

Intellia Therapeutics·interventional·Posted Nov 13, 2023·Updated Mar 27, 2026

In Brief

A Phase 3 clinical trial evaluating NTLA-2001 and Placebo for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy. Currently recruiting, targeting 1,200 participants across 132 sites in 26 countries.

Signals

Enrolling ahead of pace

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransthyretin Amyloidosis (ATTR) With Cardiomyopathy
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Portugal, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3Recruiting
20242025202620272028
First PostedNov 13, 2023
Enrollment StartDec 13, 2023
Primary CompletionDec 1, 2027
Study CompletionApr 1, 2028
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 2.6 years agoPrimary completion in 1.4 years

Interventions

NTLA-2001biological

NTLA-2001 (55mg) by IV infusion

Placebodrug

Normal saline (0.9% NaCl) by IV infusion