Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
In brief
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.
Key facts
- Study ID
- NCT07181109
- Run by
- Alnylam Pharmaceuticals
- People needed
- 11000
- Starts
- 2025-09-22
- Expected to finish
- 2030-09-30
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is 18 years or older for patients with established cardiovascular disease (CVD)
- Is 55 years or older for patients with high risk for CVD
- Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
- Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
You may not qualify if…
- Has known history of secondary hypertension
- Has symptomatic orthostatic hypotension
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×upper limit of normal (ULN)
- Has total serum bilirubin >1.5×ULN
- Has international normalized ratio (INR) >1.5
- Has serum potassium >4.8 mEq/L
- Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m\^2
Where it is running
- Clinical Trial Site — Glendale, California, United States (enrolling)
- Clinical Trial Site — Fairhope, Alabama, United States (enrolling)
- Clinical Trial Site — Foley, Alabama, United States (enrolling)
- Clinical Trial Site — Birmingham, Alabama, United States (enrolling)
- Clinical Trial Site — Huntsville, Alabama, United States (enrolling)
- Clinical Trial Site — Sheffield, Alabama, United States (enrolling)
- Clinical Trial Site — Chandler, Arizona, United States (enrolling)
- Clinical Trial Site — Gilbert, Arizona, United States (enrolling)
- Clinical Trial Site — Birmingham, Alabama, United States (enrolling)
- Clinical Trial Site — Mesa, Arizona, United States (enrolling)
- Clinical Trial Site — Phoenix, Arizona, United States (enrolling)
- Clinical Trial Site — Phoenix, Arizona, United States (enrolling)
- Clinical Trial Site — Sun City, Arizona, United States (enrolling)
- Clinical Trial Site — Sun City West, Arizona, United States (enrolling)
- Clinical Trial Site — Tempe, Arizona, United States (enrolling)
- Clinical Trial Site — Tucson, Arizona, United States (enrolling)
- Clinical Trial Site — Tucson, Arizona, United States (enrolling)
- Clinical Trial Site — Yuma, Arizona, United States (enrolling)
- Clinical Trial Site — Little Rock, Arkansas, United States (enrolling)
- Clinical Trial Site — Little Rock, Arkansas, United States (enrolling)
- Clinical Trial Site — Beverly Hills, California, United States (enrolling)
- Clinical Trial Site — Chula Vista, California, United States (enrolling)
- Clinical Trial Site — Covina, California, United States (enrolling)
- Clinical Trial Site — Escondido, California, United States (enrolling)
- Clinical Trial Site — Huntington Beach, California, United States (enrolling)
Full record on ClinicalTrials.gov
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