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Clinical Trials in the UK / NCT07181109
Recruiting Phase 3

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

NCT07181109 · tracked via the Priya Life Science UK tracker
Sponsor
Alnylam Pharmaceuticals
Phase
Phase 3
Started
2025-09-22
Last updated
2026-08-19

Condition(s) studied

High Risk Cardiovascular DiseaseHypertensionHigh Cardiovascular Risk

Investigational drug(s) / intervention(s)

ZilebesiranPlacebo

Zilebesiran: Zilebesiran will be administered SC

Placebo: Placebo will be administered SC

Study 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) 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1105)

FacilityCityRegionStatus
Clinical Trial Site Birmingham Alabama Recruiting
Clinical Trial Site Birmingham Alabama Not Yet Recruiting
Clinical Trial Site Birmingham Alabama Recruiting
Clinical Trial Site Fairhope Alabama Recruiting
Clinical Trial Site Foley Alabama Recruiting
Clinical Trial Site Huntsville Alabama Not Yet Recruiting
Clinical Trial Site Huntsville Alabama Recruiting
Clinical Trial Site Sheffield Alabama Recruiting
Clinical Trial Site Chandler Arizona Recruiting
Clinical Trial Site Gilbert Arizona Recruiting
Clinical Trial Site Glendale Arizona Not Yet Recruiting
Clinical Trial Site Mesa Arizona Recruiting
Clinical Trial Site Phoenix Arizona Recruiting
Clinical Trial Site Phoenix Arizona Recruiting
Clinical Trial Site Sun City Arizona Recruiting
Clinical Trial Site Sun City West Arizona Recruiting
Clinical Trial Site Tempe Arizona Recruiting
Clinical Trial Site Tucson Arizona Recruiting
Clinical Trial Site Tucson Arizona Recruiting
Clinical Trial Site Tucson Arizona Not Yet Recruiting
Clinical Trial Site Yuma Arizona Recruiting
Clinical Trial Site Little Rock Arkansas Recruiting
Clinical Trial Site Little Rock Arkansas Not Yet Recruiting
Clinical Trial Site Little Rock Arkansas Recruiting
Clinical Trial Site Beverly Hills California Recruiting
Clinical Trial Site Chula Vista California Recruiting
Clinical Trial Site Covina California Recruiting
Clinical Trial Site Escondido California Recruiting
Clinical Trial Site Glendale California Recruiting
Clinical Trial Site Huntington Beach California Recruiting
Clinical Trial Site La Jolla California Not Yet Recruiting
Clinical Trial Site Lancaster California Recruiting
Clinical Trial Site Long Beach California Recruiting
Clinical Trial Site Lynwood California Recruiting
Clinical Trial Site Newhall California Recruiting
Clinical Trial Site Northridge California Recruiting
Clinical Trial Site Pasadena California Recruiting
Clinical Trial Site San Diego California Recruiting
Clinical Trial Site San Dimas California Recruiting
Clinical Trial Site San Ramon California Recruiting

+ 1065 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07181109 on ClinicalTrials.gov ↗ ← All trials in the UK