Clinical Trial

HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.
Protocol Amendment History 67 amendments
This ClinicalTrials.gov record has been amended 67 times since 2019-11-04; most recent amendment 2025-12-18.
Status change: Recruiting → Active, Not Recruiting 2021-08-17
Status change: Not Yet Recruiting → Recruiting 2019-11-27
Trial Details
NCT Number NCT04153149
Lead Sponsor Alnylam Pharmaceuticals
Conditions Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Enrollment 655 participants
Start Date 2019-11-26
Primary Completion 2024-05-08 (estimated)
Study Completion 2026-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-12