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NCT07181109ClinicalTrials.gov

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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 11,000 משתתפים1,153 אתרים35 מדינות

קטגוריות

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Present: Registered before enrolment beganFirst posted 2025-09-18; recorded start 2025-09-22
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Present: Participants are randomly assignedAllocation is recorded as randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Present: Uses blinding (masking)A masking level is recorded in the record
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 50 other studies in this databaseCounted from the lead sponsor named in the record (Alnylam Pharmaceuticals)
  • Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 995 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 11,000 participants (target), run at 1,153 sites, across 35 countries.

How this score is built
  • Enrolment38/40

    11,000 participants (target)

  • Site count25/25

    995 sites

  • Country count15/15

    34 countries

  • Planned duration10/10

    Planned over about 61 months

  • Sponsor scale6/10

    Alnylam Pharmaceuticals has led 53 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

מצבים רפואיים

  • High Risk Cardiovascular Disease
  • Hypertension
  • High Cardiovascular Risk

זכאות

זכאות
מיןהכול
גילאים18 Yearsללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 11,000 משתתפים

נותן חסות ושותפים

  • Alnylam Pharmaceuticals נותן חסות
  • Hoffmann-La Roche שותפים

זרועות והתערבויות

  • Zilebesiran 300 mgEXPERIMENTAL

    Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.

  • PlaceboPLACEBO_COMPARATOR

    Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.

התערבויות

  • תרופה Placebo

    Placebo will be administered SC

  • תרופה Zilebesiran

    Zilebesiran will be administered SC

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)

    מסגרת זמן Up to approximately 5 years

  2. מדד תוצאה משני

    Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6

    מסגרת זמן Baseline and Month 6

  3. מדד תוצאה משני

    Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke

    מסגרת זמן Up to approximately 5 years

  4. מדד תוצאה משני

    Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)

    מסגרת זמן Up to approximately 5 years

  5. מדד תוצאה משני

    Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization

    מסגרת זמן Up to approximately 5 years

  6. מדד תוצאה משני

    Time to All-cause Death

    מסגרת זמן Up to approximately 5 years

תאריכים

תאריכים
תאריך התחלה22 בספטמבר 2025 (בפועל)
סיום ראשוני23 בספטמבר 2030 (משוער)
סיום23 בספטמבר 2030 (משוער)
פורסם לראשונה18 בספטמבר 2025 (בפועל)
עודכן לאחרונה18 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

922 אתרים מגייסים

Argentina

Argentina
מתקןעירמדינה או אזורמצב
Clinical Trial SiteBahía Blancaמגייס
Clinical Trial SiteBahía Blancaמגייס
Clinical Trial SiteBuenos Airesמגייס
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Clinical Trial SiteCiudadelaמגייס
Clinical Trial SiteCoronel Suárezמגייס
Clinical Trial SiteCorrientesמגייס
Clinical Trial SiteCórdobaמגייס
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Clinical Trial SiteEsperanzaמגייס
Clinical Trial SiteFormosaמגייס
Clinical Trial SiteGeneral San Martínמגייס
Clinical Trial SiteGranadero Baigorriaמגייס
Clinical Trial SiteLanús Esteמגייס
Clinical Trial SiteMar del Plataמגייס
Clinical Trial SiteMar del Plataמגייס
Clinical Trial SiteMorónמגייס
Clinical Trial SiteQuilmesטרם מגייס
Clinical Trial SiteRamos Mejíaמגייס
Clinical Trial SiteRosarioטרם מגייס
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Clinical Trial SiteRío Cuartoמגייס

1,103 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 18 בספטמבר 2026

    תאריך הסיום הוקדם

    Primary completion advanced 7 days

    2030-09-302030-09-23

  2. 18 בספטמבר 2026

    אתר נוסף

    48 sites added (1153 total)

    11051153

  3. 19 באוגוסט 2026

    אתר נוסף

    110 sites added (1105 total)

    9951105