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

Study acronym: ZENITH

StatusRecruiting

PhasePhase 3

SponsorAlnylam Pharmaceuticals

Started2025-09-22

View on ClinicalTrials.gov ↗

Amendment history

2026-09-19

Trial sites expanded: 1105 → 1153 locations

2026-08-18

Study Status, Contacts/Locations v10

Trial sites expanded: 995 → 1105 locations

2026-07-10

Study Status v9

Re-verified, no change to tracked fields

2026-07-09

Study Status, Contacts/Locations v8

Trial sites expanded: 856 → 995 locations

2026-06-10

Study Status, Contacts/Locations v7

Trial sites expanded: 742 → 856 locations

2026-05-12

Study Status, Contacts/Locations v6

Trial sites expanded: 597 → 742 locations

2026-04-16

Study Status, Contacts/Locations v5

Trial sites expanded: 229 → 597 locations

2026-03-30

Study Status v4

Re-verified, no change to tracked fields

2026-02-19

Study Status, Contacts/Locations v3

Primary completion date2030-10-29→2030-09-30

Completion date2030-10-29→2030-09-30

Study sites30→229

2025-11-03

Study Status v2

Start dateestimated 2025-10-24→confirmed 2025-09-22

2025-10-16

Study Status, Contacts/Locations v1

Study sites1→30

2025-09-12

Original filing

Alnylam Pharmaceuticals

31 trials monitored

See 5 trials at risk

Heart Disease

2,117 trials monitored

See 101 trials at risk

Hypertension

1,786 trials monitored

See 77 trials at risk

The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.

Trial Details

NCT Number	NCT07181109
Lead Sponsor	Alnylam Pharmaceuticals Collaborators: Hoffmann-La Roche
Conditions	High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
Enrollment	11,000 participants
Start Date	2025-09-22
Primary Completion	2030-09-23 (estimated)
Study Completion	2030-09-23 (estimated)
Updated on ClinicalTrials.gov	2026-09-18