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Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication

NCT05103332•Alnylam Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Office SBP at Screening as follows:
•1. ≥155 mmHg and ≤180 mmHg for patients with untreated hypertension
•2. ≥145 mmHg and ≤180 mmHg for patients on antihypertensive medications
•24-hour mean SBP ≥130 mmHg and ≤160 mmHg by ABPM after at least 4 weeks of run-in

Exclusion Criteria

•Secondary hypertension, orthostatic hypotension
•Elevated potassium \<lower limit of normal (LLN) range or \>5 milliequivalents per liter (mEq/L)
•Estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m\^2
•Received an investigational agent within the last 30 days
•Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, or laboratory evidence of diabetes during screening without known diagnosis of diabetes
•History of any cardiovascular event within 6 months prior to randomization
•History of intolerance to SC injection(s)

Locations (110)

Clinical Trial Site

Mesa, Arizona, United States

Clinical Trial Site

Tempe, Arizona, United States

Clinical Trial Site

Tempe, Arizona, United States

Clinical Trial Site

Bell Gardens, California, United States

Clinical Trials Site

Beverly Hills, California, United States

Clinical Trial Site

Canoga Park, California, United States

Clinical Trial Site

Carlsbad, California, United States

Clinical Trial Site

Encinitas, California, United States

Clinical Trial Site

Garden Grove, California, United States

Clinical Trial Site

Hollywood, California, United States

Key Dates

Start Date

November 5, 2021

Primary Completion Date

December 11, 2023

Completion Date

September 13, 2024

Last Updated

November 3, 2025

Enrollment

663

ACTUAL participants

Conditions

Hypertension

Interventions

Indapamide

DRUG

Amlodipine

DRUG

Olmesartan

DRUG

Placebo

DRUG

Zilebesiran

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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