NCT05103332

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 663 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Indapamide	Indapamide administered orally
DRUG	Amlodipine	Amlodipine administered orally
DRUG	Olmesartan	Olmesartan administered orally
DRUG	Placebo	Placebo administered by SC injection
DRUG	Zilebesiran	Zilebesiran administered by SC injection

Timeline

• Start date: 2021-11-05
• Primary completion: 2023-12-11
• Completion: 2024-09-13
• First posted: 2021-11-02
• Last updated: 2025-11-03
• Results posted: 2025-07-09

Locations

110 sites across 8 countries: United States, Canada, Estonia, Germany, Latvia, Lithuania, Poland, United Kingdom

Regulatory

• FDA-regulated drug study