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

NCT07223203 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-05-14

No results posted yet for this study

Summary

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

  • Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy
  • hATTR-PN

Interventions

DRUG

Nucresiran

Nucresiran 300 mg administered SC q6M

DRUG

Vutrisiran

Vutrisiran 25 mg administered SC q3M

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2027-12-27
Completion
2031-06-12
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • France
  • Italy
  • Japan
  • Malaysia
  • Portugal
  • South Korea
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223203 on ClinicalTrials.gov