KARDIA-1
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Efficacy and Safety of ALN-AGT01 in Patients with Mild-to-Moderate Hypertension
IRAS ID
1004480
Contact name
Holly Maier
Contact email
Sponsor organisation
Alnylam Pharmaceuticals, Inc.
Eudract number
2021-001248-82
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 lowers blood pressure when given as a sole antihypertensive treatment.
- How zilebesiran moves around and works in the body.
- If there are potential side effects of zilebesiran when it is given to patients.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 375 participants will be recruited worldwide at around 100 study sites.
This study consists of three periods:
1. Screening period lasting up-to 60 days, including a wash-out period for any current antihypertensive medications, to check that participants qualify for the study.
2. Double-blind treatment period lasting 12 months to see if zilebesiran is more effective than placebo at treating hypertensive and to study its safety.
3. Optional open-label treatment period to investigate if zilebesiran is effective and safe for a longer period.REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0165
Date of REC Opinion
21 Apr 2022
REC opinion
Further Information Favourable Opinion