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MAGNITUDE: a Phase 3 Study of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
Study details:
This is a multinational, multicenter, double-blind, placebo-controlled study in approximately 765 participants, who will be randomized to receive a single infusion of either NTLA-2001 or placebo.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-13
Primary completion: 2027-12-01
Study completion finish: 2028-04-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06128629
Intervention or treatment
BIOLOGICAL: NTLA-2001
DRUG: Placebo
Conditions
- • Transthyretin Amyloidosis (ATTR) with Cardiomyopathy
Find a site
Closest Location:
Royal Adelaide Hospital
Research sites nearby
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, Not Specified, Australia
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Cairns Hospital
Cairns, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: NTLA-2001
| BIOLOGICAL: NTLA-2001
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Composite outcome of cardiovascular (CV) mortality and CV events | Not Specified | Maximum study duration is dependent on event rates and is estimated to be at least 18 months and up to 48 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change in baseline to month 18 in serum TTR | Not Specified | Baseline, Month 18 |
Change from baseline to month 18 in KCCQ-OS score | Not Specified | Baseline, Month 18 |
Frequently Asked Questions
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