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Zilebesiran for High Blood Pressure (KARDIA-3 Trial)

Phase 2
Recruiting
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to see if adding zilebesiran to the treatment of patients with high cardiovascular risk and high blood pressure, that is not well controlled with usual medications, can improve their condition.

Who is the study for?
This trial is for adults with high blood pressure not well-managed by 2-4 standard medications and who have a history of heart disease or are at high risk for it. They should have specific blood pressure readings and a moderately reduced kidney function but not severe kidney issues.
What is being tested?
The study tests Zilebesiran, added to usual blood pressure meds, against a placebo. It aims to see if Zilebesiran better controls blood pressure in those at high risk for heart problems.
What are the potential side effects?
Potential side effects of Zilebesiran may include reactions at the injection site, low blood pressure, dizziness, abnormal kidney function tests, and possibly allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZilebesiranExperimental Treatment1 Intervention
Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo on Day 1 of the 6-month DB treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.

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Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
75 Previous Clinical Trials
14,718 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,834 Previous Clinical Trials
8,079,390 Total Patients Enrolled
~195 spots leftby Mar 2025
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