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RecruitingPhase 3

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

Alnylam Pharmaceuticals · with Hoffmann-La Roche · NCT07181109

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
11000
US sites recruiting
263
Study start
September 6, 2025
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Zilebesiran; Placebo

Conditions: High Risk Cardiovascular Disease; Hypertension; High Cardiovascular Risk

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

+ 203 more on the official record.

Study contacts (from the official record)

  • Clinical Trial Information Line · 1-877-ALNYLAM · clinicaltrials@alnylam.com
  • Clinical Trial Information Line · 1-877-256-9526 · clinicaltrials@alnylam.com
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Zilebesiran in Patients With Hypertension Not Adequately… (NCT07181109) | Bored Studies