Zilebesiran for High Blood Pressure
(KARDIA-2 Trial)

Recruiting in Palo Alto (17 mi)

+164 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alnylam Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing zilebesiran, a medication that may help lower blood pressure, in patients who need extra help managing their high blood pressure. It works by influencing body processes that regulate blood pressure.

Research Team

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

Your average blood pressure over 24 hours is between 130 and 160 mmHg.

My average blood pressure is between 130 and 160 mmHg after 4 weeks on certain blood pressure meds.

My blood pressure is between 145 and 180 mmHg while on medication.

See 3 more

Exclusion Criteria

My kidney function is severely reduced.

Your blood has too much potassium, over 5 mEq/L.

Received an investigational agent within the last 30 days

See 4 more

Treatment Details

Interventions

Zilebesiran (siRNA)

Trial OverviewThe 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.

Participant Groups

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. Upon implementation of Amendment 3, the open-label extension (OLE) period will be closed and participants will not receive any further treatment with zilebesiran in the OLE 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. Upon implementation of Amendment 3, the OLE period will be closed and participants will not receive any further treatment with zilebesiran in the OLE 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. Upon implementation of Amendment 3, the OLE period will be closed and participants will not receive any further treatment with zilebesiran in the OLE 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. Upon implementation of Amendment 3, the OLE period will be closed and participants will not receive any further treatment with zilebesiran in the OLE 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. Upon implementation of Amendment 3, the OLE period will be closed and participants will not receive any further treatment with zilebesiran in the OLE 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. Upon implementation of Amendment 3, the OLE period will be closed and participants will not receive any further treatment with zilebesiran in the OLE period.