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ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522960-34-00
Enrollment
1190
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Established cardiovascular disease, High cardiovascular risk, Hypertension

Brief summary

01. Time to first occurrence of a composite endpoint of CV death, nonfatal MI, nonfatal stroke, or HF event (hospitalization for HF or urgent HF visit).

Detailed description

01. Change from baseline in mean seated office SBP at Month 6, 02. Time to first occurrence of a composite endpoint of CV death, nonfatal MI, or nonfatal stroke, 03. Composite endpoint of CV death and total (first and subsequent) HF events (hospitalization for HF or urgent HF visit), 04. Time to first occurrence of composite endpoint of CV death, nonfatal MI, nonfatal stroke, or coronary revascularization, 05. Time to all-cause death

Interventions

DRUGZilebesiran
DRUG0.9% (w/v) sodium chloride with 5 mM phosphate buffered solution

Sponsors

Alnylam Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
01. Time to first occurrence of a composite endpoint of CV death, nonfatal MI, nonfatal stroke, or HF event (hospitalization for HF or urgent HF visit).—

Secondary

MeasureTime frame
01. Change from baseline in mean seated office SBP at Month 6, 02. Time to first occurrence of a composite endpoint of CV death, nonfatal MI, or nonfatal stroke, 03. Composite endpoint of CV death and total (first and subsequent) HF events (hospitalization for HF or urgent HF visit), 04. Time to first occurrence of composite endpoint of CV death, nonfatal MI, nonfatal stroke, or coronary revascularization, 05. Time to all-cause death—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026