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).

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507220-23-00

Acronym

ITL-2001-CL-301

Enrollment

362

Registered

2024-06-05

Start date

2024-07-26

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin Amyloidosis with Cardiomyopathy

Brief summary

Composite outcome of cardiovascular (CV) mortality and CV events

Detailed description

1. Change from baseline to month 18 in serum TTR, 2. Change from baseline to month 18 in KCCQ-OS score

Interventions

DRUGCetirizin HEXAL bei Allergien 10 mg Filmtabletten

DRUG-

DRUGParacetamol STADA® 500 mg Tabletten

DRUGDexamethason 8 mg GALEN® Tabletten

DRUGNTLA-2001

DRUGFamotidin STADA® 20 mg Filmtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Composite outcome of cardiovascular (CV) mortality and CV events	—

Secondary

Measure	Time frame
1. Change from baseline to month 18 in serum TTR, 2. Change from baseline to month 18 in KCCQ-OS score	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026