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Taking people in SingaporePhase 3

Tests NTLA-2001 against placebo in transthyretin amyloidosis with heart disease

Tests a single NTLA-2001 dose against placebo in adults with heart disease from transthyretin amyloidosis.

Key facts

Who runs it
Intellia Therapeutics
Where
Singapore, SingaporeSee the 2 sitesAlso in 26 other countries, 141 sites
Trial code
Registry title
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Status
Recruiting
Phase
Phase 3
People taking part
1,200 people, planned
Started
13 Dec 2023
Expected to end
Apr 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • NTLA-2001
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with transthyretin amyloidosis that affects the heart (ATTR-CM) and a history of heart failure. It tests a single dose of NTLA-2001 against placebo.

Age
18 to 90 years
Sex
All sexes can join.
Disease stage
Documented ATTR amyloidosis with cardiomyopathy and a history of heart failure. Heart failure symptoms must be well managed and stable for 28 days before treatment. NYHA Class IV heart failure is not allowed.
Earlier treatment
No RNA silencer therapy (patisiran, inotersen, eplontersen) within 12 months before dosing. No prior vutrisiran. No start of tafamidis or acoramidis within 56 days before dosing.
Biomarker or test result
NT-proBNP in the blood of 600 pg/mL or more and less than 10,000 pg/mL at screening.

Main reasons for not taking part

  • NYHA Class IV heart failure
  • Polyneuropathy Disability score of IV (confined to wheelchair or bed)
  • Hepatitis B, hepatitis C or HIV infection
  • Active cancer within 3 years before screening
  • Liver disease, or eGFR below 30 mL/min/1.73m^2

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • New York Heart Association (NYHA) Class IV HF
  • Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
  • History of liver disease
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m\^2
  • Polyneuropathy Disability score of IV (confined to wheelchair or bed)
  • Uncontrolled blood pressure
  • Unable or unwilling to take vitamin A supplementation for the duration of the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 90 years old?

Where in Singapore

Also in 26 other countries, 141 sites

  • National Heart CentreSingapore, SingaporeContact: Trial Manager at IntelliaTaking people
  • National University HospitalSingapore, SingaporeContact: Trial Manager at IntelliaTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • NTLA-2001Treatment being tested

    Single intravenous (IV) infusion of NTLA-2001

  • PlaceboPlacebo, for comparison

    Single IV infusion of normal saline

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests NTLA-2001 against placebo in transthyretin amyloidosis with heart diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06128629, who can take part
Record updated
4 November 2026