NCT07052903

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: * Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events * Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death * Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life

Conditions

• Transthyretin Amyloidosis With Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Nucresiran	Nucresiran 300 mg administered SC q6M
DRUG	Sterile Normal Saline (0.9% NaCl)	Sterile Normal Saline (0.9% NaCl) administered SC once q6M

Timeline

• Start date: 2025-07-02
• Primary completion: 2030-05-28
• Completion: 2032-11-30
• First posted: 2025-07-08
• Last updated: 2026-04-17

Locations

207 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study