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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

ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares zilebesiran with a placebo (a treatment with no active drug). It tests whether zilebesiran lowers the risk of death from heart or blood vessel disease, nonfatal heart attacks or strokes, or heart failure events. It is for people whose high blood pressure is not well controlled and who have heart or blood vessel disease or a high risk of it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older if you have heart or blood vessel disease.
  • Are age 55 or older if you are at high risk for heart or blood vessel disease.
  • Have disease in the blood vessels of the heart, brain, or other parts of the body, or are at high risk for it.
  • Take at least 2 standard blood pressure medicines on a stable treatment plan. One must be a thiazide, thiazide-like, or loop diuretic (a water pill).

Who can't join

  • Have a known history of high blood pressure caused by another health condition.
  • Have a drop in blood pressure when standing that causes symptoms.
  • Have ALT or AST liver test levels more than 3 times the upper normal limit.
  • Have bilirubin (a substance measured in a liver blood test) more than 1.5 times the upper normal limit.
  • Have an INR (a blood-clotting test result) above 1.5.
  • Have a blood potassium level above 4.8 mEq/L.
  • Have an eGFR (a measure of how well your kidneys filter blood) below 30 mL/min/1.73 m².

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (273)

AL

AR

AZ

CA

CO

CT

FL

GA

IL

IN

KS

KY

LA

MD

MI

MN

MO

MS

NC

ND

NE

NH

NJ

NM

NV

NY

OH

OK

PA

SC

SD

TN

TX

UT

VA

WA

WI