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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Cardiovascular Risk
• Hypertension

Interventions

Type	Name	Description
DRUG	Zilebesiran	Zilebesiran administered by subcutaneous (SC) injection
DRUG	Placebo	Placebo administered by SC injection

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-06-19
• Completion: 2025-12-01
• First posted: 2024-02-22
• Last updated: 2026-03-02

Locations

195 sites across 6 countries: United States, Australia, Canada, Puerto Rico, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study