Zilebesiran as Add-on in Patients With High CV Risk and HTN Not Adequately Controlled (KARDIA-3)
Research type
Research Study
Full 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
IRAS ID
1009599
Contact name
Holly Maier
Contact email
Sponsor organisation
Alnylam Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
The main aim of this phase II study is to evaluate efficacy and safety of zilebesiran when given subcutaneously (injected under the skin) as an add-on therapy in patients with high blood pressure. It will be evaluated in adult Patients with High Cardiovascular Risk and Hypertension not Adequately Controlled by Standard of Care Antihypertensive Medications
Zilebesiran is a type of medicine, called a ribonucleic acid interference (RNAi) therapeutic, which can reduce the amount of a protein called angiotensinogen (AGT) made by the liver. While AGT is a normal protein, too much AGT is thought to contribute to high blood pressure and several other diseases. Zilebesiran has shown to lower hepatic AGT in the body and reduce blood pressure towards normal.
Patients will be randomized to receive a single dose of 300 or 600 mg zilebesiran or placebo on Day 1 in Cohort A or 150, 300, or 600 mg zilebesiran or placebo on Day 1 in Cohort B.
Approximately 270 patients will be enrolled in Cohort A (approximately 90 per arm). Up to 120 patients will be enrolled in Cohort B (up to 30 per arm).
The duration of treatment with zilebesiran is up to 6 months. The estimated total time on study for each patient is up to 14 months, including up to 45 days of screening, 6 months of treatment, and 6 months of safety follow-up.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0166
Date of REC Opinion
22 Apr 2024
REC opinion
Further Information Favourable Opinion