Actively Recruiting

Phase 3
Age: 18Years - 85Years
All Genders
NCT07223203

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

Led by Alnylam Pharmaceuticals · Updated on 2026-05-14

125

Participants Needed

16

Research Sites

286 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has documented diagnosis of hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN)
  • Has a documented transthyretin (TTR) gene variant
  • Has a neuropathy impairment score (NIS) between 5 and 130 inclusive
  • Has a Karnofsky Performance Status (KPS) of 60% or higher
Not Eligible

You will not qualify if you...

  • Has had a liver transplant or is likely to undergo liver transplantation during the study treatment period
  • Has other known forms of amyloidosis besides hATTR or signs of leptomeningeal amyloidosis
  • Has New York Heart Association (NYHA) heart failure classification greater than 2
  • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than 2.5 times the upper limit of normal
  • Has total bilirubin level greater than 1.5 times the upper limit of normal
  • Has estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2
  • Has other known causes of sensorimotor or autonomic neuropathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Clinical Trial Site

Baltimore, Maryland, United States, 21287

Actively Recruiting

2

Clinical Trial Site

Boston, Massachusetts, United States, 02118

Actively Recruiting

3

Clinical Trial Site

Dallas, Texas, United States, 75246

Actively Recruiting

4

Clinical Trial Site

São Paulo, Brazil, 04038-002

Actively Recruiting

5

Clinical Trial Site

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

6

Clinical Trial Site

Florence, Italy, 50134

Actively Recruiting

7

Clinical Trial Site

Milan, Italy, 20133

Actively Recruiting

8

Clinical Trial Site

Suita, Japan, 565-0871

Actively Recruiting

9

Clinical Trial Site

Kuala Lumpur, Malaysia, 59100

Actively Recruiting

10

Clinical Trial Site

Porto, Portugal, 4099-001

Not Yet Recruiting

11

Clinical Trial Site

Seoul, South Korea, 05030

Actively Recruiting

12

Clinical Trial Site

Seoul, South Korea, 06351

Actively Recruiting

13

Clinical Trial Site

Stockholm, Sweden, 113 61

Actively Recruiting

14

Clinical Trial Site

Umeå, Sweden, 907 37

Actively Recruiting

15

Clinical Trial Site

Taipei, Taiwan, 112

Not Yet Recruiting

16

Clinical Trial Site

Taoyuan City, Taiwan, 333

Actively Recruiting

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Research Team

C

Clinical Trial Information Line

CONTACT

C

Clinical Trial Information Line

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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