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ZENITH: Zilebesiran in Hypertension with High Cardiovascular Risk
NCT07181109Phase 3
Key facts
- Status
- Recruiting
- Start
- Sep 2025
- Primary completion
- Sep 2030
- Countries
- 35
- Sponsor
- Alnylam Pharmaceuticals
- Drugs
- zilebesiran
- Conditions
- hypertension (HTN)
01
Overview
Phase 3, randomised, double-blind trial in hypertension (HTN) comparing Zilebesiran 300 mg with Placebo (2 arms). Primary endpoint: Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event at 5 years. Started Sep 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Zilebesiran 300 mg
Zilebesiran 300 mg SC once every 6 months + standard of care
Placebo
Placebo SC once every 6 months + standard of care
03
Who it enrols
Adults with treated but inadequately controlled hypertension on at least 2 standard of care medications (including a diuretic), who have established cardiovascular disease or are at high risk for it. Excludes patients with secondary hypertension, symptomatic orthostatic hypotension, or significant hepatic/renal impairment.
04
Endpoints
Primary
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event
Secondary
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP)
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
Time to All-cause Death
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