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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 baseline and months 3 and 6
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.Check my eligibility
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.See study design
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 ~baseline and months 3 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and months 3 and 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 Mean Seated Office Systolic Blood Pressure (SBP)
Secondary outcome measures
Change from Baseline Over Time in Serum Angiotensinogen (AGT)
Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM
Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM
+6 more

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
74 Previous Clinical Trials
14,664 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,801 Previous Clinical Trials
8,069,940 Total Patients Enrolled
~227 spots leftby Mar 2025