NCT06128629 MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
| NCT ID | NCT06128629 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Intellia Therapeutics |
| Condition | Transthyretin Amyloidosis (ATTR) With Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,200 participants in total. It began in 2023-12-13 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06128629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Transthyretin Amyloidosis (ATTR) With Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06128629 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,200 participants.
Is NCT06128629 currently recruiting?
Yes, NCT06128629 is actively recruiting participants. Contact the research team at medicalinformation@intelliatx.com for enrollment information.
Where is the NCT06128629 trial being conducted?
This trial is being conducted at Tucson, United States, Los Angeles, United States, Los Angeles, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06128629 clinical trial?
NCT06128629 is sponsored by Intellia Therapeutics. The trial plans to enroll 1,200 participants.