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Zilebesiran for High Blood Pressure (KARDIA-2 Trial)

Phase 2
Waitlist Available
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
24-hour mean SBP >130 mmHg and ≤160 mmHg by ABPM after at least 4 weeks of run-in on protocol-specified background antihypertensive medication
≥145 mmHg and ≤180 mmHg for patients on antihypertensive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and month 6
Awards & highlights

KARDIA-2 Trial Summary

This trial will study the effects of zilebesiran on blood pressure and safety in patients with uncontrolled hypertension.

Who is the study for?
This trial is for adults with high blood pressure not well-controlled by standard medications. Eligible participants have a 24-hour average systolic blood pressure between >130 and ≤160 mmHg, and office readings of ≥145 to ≤180 mmHg if on meds or ≥155 to ≤180 mmHg if untreated. They can't join if they've used investigational drugs recently, have very low kidney function, unmanaged diabetes, recent heart issues, or certain other conditions.Check my eligibility
What is being tested?
The study tests Zilebesiran's ability to lower blood pressure when added to common antihypertensive drugs like Amlodipine, Indapamide, or Olmesartan. Participants will be randomly assigned either Zilebesiran or a placebo as an add-on therapy while continuing their usual hypertension medication.See study design
What are the potential side effects?
Potential side effects of Zilebesiran may include reactions at the injection site since it's given under the skin (SC), possible changes in kidney function which will be monitored due to its effect on blood pressure regulation mechanisms.

KARDIA-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My average blood pressure is between 130 and 160 mmHg after 4 weeks on certain blood pressure meds.
Select...
My blood pressure is between 145 and 180 mmHg while on medication.
Select...
My blood pressure is between 155 and 180 mmHg and I haven't treated it yet.

KARDIA-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline at Month 3 in 24-Hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
Secondary outcome measures
Change from Baseline at Month 3 in Office SBP
Change from Baseline in Serum Angiotensinogen (AGT)
Change in 24-hour Mean SBP and DBP, Assessed by ABPM
+4 more

KARDIA-2 Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Zilebesiran (Add-on to Olmesartan)Experimental Treatment2 Interventions
Following a run-in on olmesartan, eligible participants will receive zilebesiran on Day 1 of a 6-month double-blind treatment period as add-on to olmesartan. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Group II: Zilebesiran (Add-on to Amlodipine)Experimental Treatment2 Interventions
Following a run-in on amlodipine, eligible participants will receive zilebesiran on Day 1 of a 6-month double-blind treatment period as add-on to amlodipine. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Group III: Placebo (Add-on to Olmesartan)Experimental Treatment3 Interventions
Following a run-in on olmesartan, eligible participants will receive placebo on Day 1 of a 6-month double-blind treatment period as add-on to olmesartan. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Group IV: Placebo (Add-on to Amlodipine)Placebo Group3 Interventions
Following a run-in on amlodipine, eligible participants will receive placebo on Day 1 of a 6-month double-blind treatment period as add-on to amlodipine. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Group V: Placebo (Add-on to Indapamide)Placebo Group3 Interventions
Following a run-in on indapamide, eligible participants will receive placebo on Day 1 of a 6-month double-blind treatment period as add-on to indapamide. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Group VI: Zilebesiran (Add-on to Indapamide)Placebo Group2 Interventions
Following a run-in on indapamide, eligible participants will receive zilebesiran on Day 1 of a 6-month double-blind treatment period as add-on to indapamide. Thereafter, participants will receive zilebesiran once every 6 months during the open-label extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amlodipine
2004
Completed Phase 4
~40680
Olmesartan
2021
Completed Phase 4
~8630
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
72 Previous Clinical Trials
14,146 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,777 Previous Clinical Trials
8,062,814 Total Patients Enrolled

Media Library

Zilebesiran Clinical Trial Eligibility Overview. Trial Name: NCT05103332 — Phase 2
High Blood Pressure Research Study Groups: Zilebesiran (Add-on to Amlodipine), Placebo (Add-on to Amlodipine), Placebo (Add-on to Olmesartan), Zilebesiran (Add-on to Olmesartan), Placebo (Add-on to Indapamide), Zilebesiran (Add-on to Indapamide)
High Blood Pressure Clinical Trial 2023: Zilebesiran Highlights & Side Effects. Trial Name: NCT05103332 — Phase 2
Zilebesiran 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103332 — Phase 2
High Blood Pressure Patient Testimony for trial: Trial Name: NCT05103332 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become a participant in this experiment?

"This medical trial is open to 800 hypertensive individuals aged between 18 and 75 years old. In order to be eligible, the systolic blood pressure must fall within a certain range; untreated patients should have readings of 155-180 mmHg while those on antihypertensives must read 145-180mmHg. Additionally, 24 hour mean SBP needs to lie in the 130-160 mmHG band after 4 weeks of using protocol-specified medication for hypertension control."

Answered by AI

Does the trial accept participants who are of legal age?

"Per the requirements of this medical study, participants must be aged 18 to 75. There are 55 clinical trials specifically targeting individuals younger than 18 years old and 696 studies seeking patients older than 65."

Answered by AI

How many participants are eligible for this investigation?

"Affirmative. The data provided by clinicaltrials.gov indicates that this investigation, first announced on November 5th 2021, is currently searching for participants. 800 volunteers are needed from 71 different medical centres."

Answered by AI

What medical conditions can be remedied using Zilebesiran?

"Primarily used for cardiovascular events, zilebesiran can also be beneficial in managing high cardiovascular risk, dyslipidemias and the body's sodium and fluid retention."

Answered by AI

Is Zilebesiran a reliable option for those seeking medical treatment?

"Our assessment of Zilebesiran's safety is a 2. This rating was based off the fact that it has only gone through Phase 2 trials, which have provided some evidence for its security but none to support efficacy."

Answered by AI

Are there any vacant positions available for volunteers in this research undertaking?

"Affirmative. On clinicaltrials.gov, it is indicated that this study has been actively recruiting since November 5th 2021 and requires the recruitment of 800 patients from 71 different sites."

Answered by AI

Are there any existing experiments using Zilebesiran to test its efficacy?

"Initially studied in 2012 at UT Southwestern Medical Centre, zilebesiran has since been the subject of 18686 completed trials. Currently, there are 37 active studies taking place with a significant proportion hosted out of Jefferson City, Missouri."

Answered by AI

To what extent is this study being implemented in the United States?

"71 medical centres across the world are currently recruiting for this trial, with major hubs located in Jefferson City, Calgary and Houston. It is recommended to choose a nearby clinic if one wishes to limit their travel needs when participating."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Florida
Illinois
Other
How old are they?
18 - 65
What site did they apply to?
Clinical Trial Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

would like to not have to take BP meds. I applied because I'm looking for compensation.
PatientReceived 1 prior treatment
It seems no matter what I do the HBP won't go away. Need to take better care of myself. Like helping community.
PatientReceived 1 prior treatment
I have uncontrolled hypertension and am interested in new treatments.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
2021. "Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05103332.
All > Hypertension
~197 spots leftby Apr 2025
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