KARDIA-2
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 Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication
IRAS ID
1004247
Contact name
Holly Maier
Contact email
Sponsor organisation
Alnylam Pharmaceuticals, Inc.
Eudract number
2021-003776-13
Clinicaltrials.gov Identifier
Research summary
Hypertension (high blood pressure) affects 30-45% of adults and is one of the largest risk factors for cardiovascular disease, strokes and heart attacks. The disease is often not controlled with current standard therapies and new approaches of treatment that may also improve compliance is a key unmet need.
The purpose of this study is to assess a potential new treatment for hypertension called zilebesiran. Zilebesiran is a medicine which can reduce the amount of a protein called angiotensinogen (AGT) made in the liver. While AGT is a normal protein, too much AGT is thought to contribute to high blood pressure. After injection, zilebesiran is designed to travel to the liver and reduce its ability to make AGT. This is predicted to lower AGT levels in the body and to reduce blood pressure towards normal.
The main goals of the study are to learn:
• If zilebesiran further lowers blood pressure when given in addition to an oral, standard of care antihypertensive medication.
• How zilebesiran moves around and works in the body.
• If there are potential side effects of zilebesiran when it is given in combination with an oral, standard of care antihypertensive medication.This study is recruiting participants between the ages of 18 to 75 years old who have untreated hypertension or, are being treated for hypertension. Approximately 800 participants will be recruited worldwide at around 85 study sites.
This study consists of four periods:
1. Screening period lasting up-to 30 days to check that participants qualify for the study.
2. Run-in period lasting 4-6 weeks to start participants on their standard of care antihypertensive medication for at least 4 weeks.
3. Double-blind treatment period lasting 6 months to see if zilebesiran is more effective than placebo when given alongside the standard medication and to study its safety.
4. Optional open-label treatment period to investigate if zilebesiran is effective and safe for a longer period.Lay Summary of Results:
"Hypertension (high blood pressure) affects 30-45% of adults and is one of the largest risk factors for cardiovascular disease, strokes and heart attacks. The disease is often not controlled with current standard therapies and new approaches of treatment that may also improve compliance is a key unmet need.
The purpose of this study is to assess a potential new treatment for hypertension called zilebesiran. Zilebesiran is a medicine which can reduce the amount of a
protein called angiotensinogen (AGT) made in the liver. While AGT is a normal protein, too much AGT is thought to contribute to high blood pressure. After injection,
zilebesiran is designed to travel to the liver and reduce its ability to make AGT. This is predicted to lower AGT levels in the body and to reduce blood pressure
towards normal.
The main goals of the study are to learn:
• If zilebesiran further lowers blood pressure when given in addition to an oral, standard of care antihypertensive medication.
• How zilebesiran moves around and works in the body.
• If there are potential side effects of zilebesiran when it is given in combination with an oral, standard of care antihypertensive medication.
This study is recruiting participants between the ages of 18 to 75 years old who have untreated hypertension or, are being treated for hypertension. Approximately
800 participants will be recruited worldwide at around 85 study sites.
This study consists of four periods:Screening period lasting up-to 30 days to check that participants qualify for the study.
Run-in period lasting 4-6 weeks to start participants on their standard of care antihypertensive medication for at least 4 weeks.
Double-blind treatment period lasting 6 months to see if zilebesiran is more effective than placebo when given alongside the standard medication and to study its
safety.
Optional open-label treatment period to investigate if zilebesiran is effective and safe for a longer period."REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0810
Date of REC Opinion
25 Jan 2022
REC opinion
Further Information Favourable Opinion