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

Conditions

• Transthyretin Amyloidosis With Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Nucresiran — DRUG
  Nucresiran 300 mg administered SC q6M
• Sterile Normal Saline (0.9% NaCl) — DRUG
  Sterile Normal Saline (0.9% NaCl) administered SC once q6M

Study Details

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

Key Dates

Start date

Jul 2, 2025

Status verified

May 2026

Primary completion

May 28, 2030

Completion

Nov 30, 2032

Study Design

Enrollment

1,250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period.
• Experimental: Nucresiran 300 mg
  Participants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period.

Primary Outcome Measure

Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits) [ Time Frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years) ]

Central Contacts

• Clinical Trial Information Line
  1-877-ALNYLAM
  [email protected]
• Clinical Trial Information Line
  1-877-256-9526
  [email protected]

Locations (39)

Find similar trials in La Jolla, CA

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