HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
← catalyst calendarSponsored by Alnylam Pharmaceuticals (industry) · ALNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
655actual
Sites
119
Countries
Argentina, Australia, Austria +29
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-11-26 | actual | When the study began enrolling |
| Primary completion | 2024-05-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-02 | estimated | The whole study's end, after follow-up |
| First posted | 2019-11-06 | actual | When this record first appeared on the registry |
| Results posted | 2025-10-21 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Interventions
- Drug: Vutrisiran — also filed as ALN-TTRSC02
- Drug: Sterile Normal Saline (0.9% NaCl)
Primary outcomes
what the primary-completion date above is the date OFComposite Endpoint of All-Cause Mortality and Recurrent Cardiovascular (CV) Events (CV Hospitalizations and Urgent Heart Failure [HF] Visits) in the Overall Population
measured Up to Month 36
Composite Endpoint of All-Cause Mortality and Recurrent CV Events (CV Hospitalizations and Urgent HF Visits) in the Vutrisiran Monotherapy Subgroup
measured Up to Month 36
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-02-12 · 13.2 MB · Prot_002.pdf
Statistical Analysis Planposted 2024-05-30 · 4.7 MB · SAP_003.pdf
Publications
- PMID 42201475 — linked by the registry
- PMID 42165759 — linked by the registry
- PMID 41225306 — linked by the registry
- PMID 40770082 — linked by the registry
- PMID 40769675 — linked by the registry
- PMID 40380962 — linked by the registry
- PMID 40099776 — linked by the registry
- PMID 39566871 — linked by the registry
- PMID 39213194 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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