Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals
• Treatments: Amlodipine; Indapamide; Olmesartan

Criteria

Inclusion Criteria:

• Office SBP at Screening as follows:

1. ≥155 mmHg and ≤180 mmHg for patients with untreated hypertension

2. ≥145 mmHg and ≤180 mmHg for patients on antihypertensive medications

• 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

Exclusion Criteria:

• Secondary or orthostatic hypertension

• Elevated potasium >5 mEq/L

• Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m^2

• Received an investigational agent within the last 30 days

• Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus

• History of any cardiovascular event within 6 months prior to randomization

• History of intolerance to SC injection(s)