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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

11000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2030-10-29

Brief Summary

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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.

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Detailed Description

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Conditions

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High Risk Cardiovascular Disease Hypertension High Cardiovascular Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zilebesiran 300 mg

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

Group Type EXPERIMENTAL

Zilebesiran

Intervention Type DRUG

Zilebesiran will be administered SC

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered SC

Interventions

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Zilebesiran

Zilebesiran will be administered SC

Intervention Type DRUG

Placebo

Placebo will be administered SC

Intervention Type DRUG

Other Intervention Names

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ALN-AGT01

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No