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NCT07223203PHASE3Recruiting

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

Alnylam Pharmaceuticals

Start Date

12/12/2025

Completion Date

6/12/2031

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

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

DRUG

Nucresiran

DRUG

Vutrisiran

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Conditions

Hereditary Transthyretin-Mediated Amyloidosis With PolyneuropathyhATTR-PN

Locations

Clinical Trial Site

Aurora, Colorado 80045

United States

Clinical Trial Site

Chicago, Illinois 60611

United States

Clinical Trial Site

Baltimore, Maryland 21287

United States

Clinical Trial Site

Boston, Massachusetts 02118

United States

Clinical Trial Site

Rochester, Minnesota 55905

United States

Clinical Trial Site

New York, New York 10032

United States

Clinical Trial Site

Chapel Hill, North Carolina 27514

United States

Clinical Trial Site

Dallas, Texas 75246

United States

Clinical Trial Site

Houston, Texas 77030

United States

Clinical Trial Site

Darlinghurst, 2010

Australia

Clinical Trial Site

Woolloongabba, 4102

Australia

Clinical Trial Site

Ribeirão Preto, 14051-140

Brazil

Clinical Trial Site

São Paulo, 04038-002

Brazil

Clinical Trial Site

Égkomi, 2371

Cyprus

Clinical Trial Site

Créteil, 94000

France

Clinical Trial Site

Le Kremlin-Bicêtre, 94270

France

Clinical Trial Site

Marseille, 13005

France

Clinical Trial Site

Berlin, 10117

Germany

Clinical Trial Site

Münster, 48149

Germany

Clinical Trial Site

Athens, 115 28

Greece

Clinical Trial Site

Heraklion, 715 00

Greece

Clinical Trial Site

Florence, 50134

Italy

Clinical Trial Site

Milan, 20133

Italy

Clinical Trial Site

Pavia, 27100

Italy

Clinical Trial Site

Roma, 00168

Italy

Clinical Trial Site

Kumamoto, 860-8556

Japan

Clinical Trial Site

Suita, 565-0871

Japan

Clinical Trial Site

Kuala Lumpur, 59100

Malaysia

Clinical Trial Site

Lisbon, 1649-035

Portugal

Clinical Trial Site

Porto, 4099-001

Portugal

Clinical Trial Site

Seoul, 05030

South Korea

Clinical Trial Site

Seoul, 06351

South Korea

Clinical Trial Site

Barcelona, 08035

Spain

Clinical Trial Site

Huelva, 21005

Spain

Clinical Trial Site

L'Hospitalet de Llobregat, 8907

Spain

Clinical Trial Site

Stockholm, 113 61

Sweden

Clinical Trial Site

Umeå, 907 37

Sweden

Clinical Trial Site

Taipei, 10002

Taiwan

Clinical Trial Site

Taipei, 112

Taiwan

Clinical Trial Site

Taoyuan City, 333

Taiwan

Clinical Trial Site

Istanbul, 34093

Turkey (Türkiye)