NCT06672237 A Phase 3 Study of NTLA-2001 in ATTRv-PN
| NCT ID | NCT06672237 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Intellia Therapeutics |
| Condition | Neuromuscular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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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 60 participants in total. It began in 2024-11-22 with a primary completion date of 2027-07.
⚠ 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
This study will be conducted to evaluate the efficacy and safety of a single dose of nexiguran ziclumeran (NTLA-2001) compared to placebo in participants with ATTRv-PN.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of ATTRv-PN * Karnofsky Performance Status (KPS) ≥ 60 Exclusion Criteria: * Other causes of amyloidosis (amyloidosis caused by non-TTR protein) * Other known causes of sensorimotor or autonomic neuropathy * Diabetes mellitus * New York Heart Association Class III or IV heart failure * Liver failure * Hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection * Prior receipt of a TTR silencer (Small interfering RNA (siRNA) or Antisense oligonucleotides (ASOs)) * Estimated Glomerular Filtration Rate \< 30 mL/min/1.73 m2 * Unable or unwilling to take vitamin A supplementation for the duration of the study * History of liver disease
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06672237 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Neuromuscular Disease. 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 NCT06672237 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 60 participants.
Is NCT06672237 currently recruiting?
Yes, NCT06672237 is actively recruiting participants. Contact the research team at medicalinformation@intelliatx.com for enrollment information.
Where is the NCT06672237 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Buenos Aires, Argentina, San Juan Bautista, Argentina, Campinas, Brazil and 10 additional locations.
Who is sponsoring the NCT06672237 clinical trial?
NCT06672237 is sponsored by Intellia Therapeutics. The trial plans to enroll 60 participants.