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RECRUITING Phase 3 ClinicalTrials.gov

TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy

Sponsor: Alnylam Pharmaceuticals • ClinicalTrials.gov ID: NCT07223203

Registry updated: 2026-10-08
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Description

The purpose of this study is to: * Determine the efficacy of nucresiran in patients with hATTR-PN by evaluating the effect on neurologic impairment, quality of life, nutritional status, disability, and gait speed * Demonstrate superiority of nucresiran compared to in-study vutrisiran with respect to serum transthyretin (TTR) levels

Interventions

  • Nucresiran (Drug)
    Nucresiran 300 mg administered SC q6M
  • Vutrisiran (Drug)
    Vutrisiran 25 mg administered SC q3M

Eligibility criteria

Inclusion Criteria: * Has documented diagnosis of hATTR-PN * Has a diagnosis of hATTR amyloidosis with polyneuropathy with a documented TTR gene variant * Has a neuropathy impairment score (NIS) of 5 to 130 (inclusive) * Has a Karnofsky Performance Status (KPS) of ≥60% Exclusion Criteria: * Has had a liver transplant or is likely, in the opinion of the Investigator, to undergo liver transplantation during the Treatment Period of the study * Has known other (non-hATTR) forms of amyloidosis or clinical evidence of leptomeningeal amyloidosis * Has a New York Heart Association (NYHA) heart failure classification \>2 * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN) * Has total bilirubin \>1.5 ULN * Has estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m\^2 * Has other known causes of sensorimotor or autonomic neuropathy

Conditions

Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy hATTR-PN

Locations

  • Clinical Trial Site — Aurora, Colorado, United States
  • Clinical Trial Site — Chicago, Illinois, United States
  • Clinical Trial Site — Baltimore, Maryland, United States
  • Clinical Trial Site — Boston, Massachusetts, United States
  • Clinical Trial Site — Rochester, Minnesota, United States
  • Clinical Trial Site — New York, New York, United States
  • Clinical Trial Site — New York, New York, United States
  • Clinical Trial Site — Chapel Hill, North Carolina, United States
  • Clinical Trial Site — Nashville, Tennessee, United States
  • Clinical Trial Site — Dallas, Texas, United States
  • Clinical Trial Site — Houston, Texas, United States
  • Clinical Trial Site — Belgrano, Argentina
  • Clinical Trial Site — Rosario, Argentina
  • Clinical Trial Site — Darlinghurst, Australia
  • Clinical Trial Site — Woolloongabba, Australia
  • Clinical Trial Site — Ribeirão Preto, Brazil
  • Clinical Trial Site — Rio de Janeiro, Brazil
  • Clinical Trial Site — Rio de Janeiro, Brazil
  • Clinical Trial Site — Salvador, Brazil
  • Clinical Trial Site — São Paulo, Brazil
  • Clinical Trial Site — Vancouver, Canada
  • Clinical Trial Site — Égkomi, Cyprus
  • Clinical Trial Site — Créteil, France
  • Clinical Trial Site — Le Kremlin-Bicêtre, France
  • Clinical Trial Site — Marseille, France
  • Clinical Trial Site — Berlin, Germany
  • Clinical Trial Site — Heidelberg, Germany
  • Clinical Trial Site — Münster, Germany
  • Clinical Trial Site — Athens, Greece
  • Clinical Trial Site — Heraklion, Greece
  • Clinical Trial Site — Dublin, Ireland
  • Clinical Trial Site — Florence, Italy
  • Clinical Trial Site — Milan, Italy
  • Clinical Trial Site — Padova, Italy
  • Clinical Trial Site — Pavia, Italy
  • Clinical Trial Site — Roma, Italy
  • Clinical Trial Site — Bunkyo C, Japan
  • Clinical Trial Site — Kumamoto, Japan
  • Clinical Trial Site — Matsumoto-shi, Japan
  • Clinical Trial Site — Suita, Japan
  • Clinical Trial Site — Kuala Lumpur, Malaysia
  • Clinical Trial Site — Guadalajara, Mexico
  • Clinical Trial Site — Tlalpan, Mexico
  • Clinical Trial Site — Lisbon, Portugal
  • Clinical Trial Site — Porto, Portugal
  • Clinical Trial Site — Seoul, South Korea
  • Clinical Trial Site — Seoul, South Korea
  • Clinical Trial Site — Barcelona, Spain
  • Clinical Trial Site — Huelva, Spain
  • Clinical Trial Site — L'Hospitalet de Llobregat, Spain
  • Clinical Trial Site — Madrid, Spain
  • Clinical Trial Site — Palma de Mallorca, Spain
  • Clinical Trial Site — Stockholm, Sweden
  • Clinical Trial Site — Umeå, Sweden
  • Clinical Trial Site — Bern, Switzerland
  • Clinical Trial Site — Taipei, Taiwan
  • Clinical Trial Site — Taipei, Taiwan
  • Clinical Trial Site — Taoyuan City, Taiwan
  • Clinical Trial Site — Istanbul, Turkey (Türkiye)
  • Clinical Trial Site — Izmir, Turkey (Türkiye)
  • Clinical Trial Site — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record