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NCT06272487 Clinical Trial

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

Hypertension Clinical Trial

— KARDIA-3  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06272487
Other study ID # ALN-AGT01-007
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 29, 2024
Est. completion date December 19, 2025

Study information
Verified date May 2024
Source Alnylam Pharmaceuticals
Contact Alnylam Clinical Trial Information Line
Phone 1-877-ALNYLAM
Email clinicaltrials@alnylam.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 390
Est. completion date December 19, 2025
Est. primary completion date March 20, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zilebesiran
Zilebesiran administered by subcutaneous (SC) injection
• Placebo
Placebo administered by SC injection

Locations
Country Name City State
Canada Clinical Trial Site Brampton Ontario
Canada Clinical Trial Site Chicoutimi Quebec
Canada Clinical Trial Site Montréal Quebec
Canada Clinical Trial Site Sarnia Ontario
United States Clinical Trial Site Alexander City Alabama
United States Clinical Trial Site Berlin New Jersey
United States Clinical Trial Site Charlotte North Carolina
United States Clinical Trial Site Clearwater Florida
United States Clinical Trial Site Coral Gables Florida
United States Clinical Trial Site Covina California
United States Clinical Trial Site Daphne Alabama
United States Clinical Trial Site Daytona Beach Florida
United States Clinical Trial Site El Dorado Kansas
United States Clinical Trial Site Flint Michigan
United States Clinical Trial Site Foley Alabama
United States Clinical Trial Site Fort Myers Florida
United States Clinical Trial Site Garden Grove California
United States Clinical Trial Site Houston Texas
United States Clinical Trial Site Houston Texas
United States Clinical Trial Site Huntington Beach California
United States Clinical Trial Site Huntsville Alabama
United States Clinical Trial Site Jacksonville Florida
United States Clinical Trial Site Jacksonville Florida
United States Clinical Trial Site Las Vegas Nevada
United States Clinical Trial Site Miami Florida
United States Clinical Trial Site Miami Florida
United States Clinical Trial Site Miami Florida
United States Clinical Trial Site Monroe North Carolina
United States Clinical Trial Site New Orleans Louisiana
United States Clinical Trial Site Newton Kansas
United States Clinical Trial Site Norman Oklahoma
United States Clinical Trial Site North Miami Beach Florida
United States Clinical Trial Site Northridge California
United States Clinical Trial Site Northridge California
United States Clinical Trial Site Orlando Florida
United States Clinical Trial Site Owensboro Kentucky
United States Clinical Trial Site Pasadena California
United States Clinical Trial Site Phoenix Arizona
United States Clinical Trial Site Rapid City South Dakota
United States Clinical Trial Site San Antonio Texas
United States Clinical Trial Site Santa Ana California
United States Clinical Trial Site Savannah Georgia
United States Clinical Trial Site Sherman Texas
United States Clinical Trial Site Splendora Texas
United States Clinical Trial Site Stephenville Texas
United States Clinical Trial Site Tempe Arizona
United States Clinical Trial Site Tomball Texas
United States Clinical Trial Site Washington District of Columbia
United States Clinical Trial Site West Hills California
United States Clinical Trial Site Wichita Kansas
United States Clinical Trial Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Alnylam Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) Baseline and Month 3
Secondary Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) Baseline and Month 3
Secondary Change from Baseline at Month 6 in Mean Seated Office SBP Baseline and Month 6
Secondary Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM Baseline and Month 6
Secondary Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction =10 mmHg without Intensification of Antihypertensive Regimen at Month 6 Month 6
Secondary 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 Month 6
Secondary Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM Baseline and Months 3 and 6
Secondary Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP Baseline and Months 3 and 6
Secondary Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM Baseline and Months 3 and 6
Secondary Change from Baseline Over Time in Serum Angiotensinogen (AGT) Baseline through Month 6
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