Status:
RECRUITING
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Lead Sponsor:
Alnylam Pharmaceuticals
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
High Risk Cardiovascular Disease
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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) e...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2030
Estimated Enrollment :
11000 Patients enrolled
Trial Details
Trial ID
NCT07181109
Start Date
September 22 2025
End Date
October 29 2030
Last Update
November 4 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Site
Phoenix, Arizona, United States, 85020
2
Clinical Trial Site
Tucson, Arizona, United States, 85741
3
Clinical Trial Site
Little Rock, Arkansas, United States, 72204
4
Clinical Trial Site
Escondido, California, United States, 92025