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Completed

NCT Number: NCT06272487

Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)

The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.

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Key information

Conditions

High Cardiovascular Risk Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site, Blacktown, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to <60 mL/min/1.73m^2
  • Mean seated office SBP ≥140 mmHg and ≤170 mmHg
  • 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM
  • Must be on stable therapy with 2 to 4 classes of antihypertensive medications

Exclusion criteria

  • Secondary hypertension
  • Orthostatic hypotension
  • Proteinuria >3 g/day
  • Serum potassium >4.8 milliequivalents per liter (mEq/L)

Treatment and study plan

Zilebesiran

Drug

Zilebesiran administered by subcutaneous (SC) injection

Other names: ALN-AGT01

Placebo

Drug

Placebo administered by SC injection

Primary outcomes

  1. Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP)

    Time frame: Baseline and Month 3

Secondary outcomes

  1. Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)

    Time frame: Baseline and Month 3

  2. Change from Baseline at Month 6 in Mean Seated Office SBP

    Time frame: Baseline and Month 6

  3. Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM

    Time frame: Baseline and Month 6

  4. Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6

    Time frame: Month 6

  5. Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6

    Time frame: Month 6

  6. Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM

    Time frame: Baseline and Months 3 and 6

  7. Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP

    Time frame: Baseline and Months 3 and 6

  8. Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM

    Time frame: Baseline and Months 3 and 6

  9. Change from Baseline Over Time in Serum Angiotensinogen (AGT)

    Time frame: Baseline through Month 6

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: KARDIA-3

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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