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A Phase 3 Study of NTLA-2001 in ATTRv-PN

RecruitingPhase 3Ages 18 Years - 85 YearsAllIntellia Therapeutics
NCT06672237 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • nexiguran ziclumeran
  • Normal Saline as Placebo
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Where

14 sites
Hospital Británico de Buenos Aires
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, Argentina
Hospital El Cruce
San Juan Bautista, Argentina
Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)
Campinas, Brazil
HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude
Rio de Janeiro, Brazil
PSEG Centro de Pesquisa Clinica S.A.
São Paulo, Brazil
National Institute of Medical Sciences and Nutrition - Salvador Zubiran (INCMNSZ)
Tlalpan, Mexico

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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