Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

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NCT07181109 · readout in 1,502 d

Sponsored by Alnylam Pharmaceuticals (industry) · ALNY — their whole pipeline →. With Hoffmann-La Roche.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

11,000estimated

Sites

1,105

Countries

Argentina, Australia, Austria +31

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

2025-09-22

actual

When the study began enrolling

Primary completion

2030-09-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-09-30

estimated

The whole study's end, after follow-up

First posted

2025-09-18

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-19

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

High Risk Cardiovascular Disease
Hypertension
High Cardiovascular Risk

Interventions

Drug: Zilebesiran — also filed as ALN-AGT01
Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF

Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)

measured Up to approximately 5 years

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