A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications

ALN-AGT01-007

The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.

2024-02-29

2025-03-20

2025-12-19

Recruiting

Early phase I

390

Inclusion Criteria: * History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to \<60 mL/min/1.73m\^2 * Mean seated office SBP ≥140 mmHg and ≤170 mmHg * 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM * Must be on stable therapy with 2 to 4 classes of antihypertensive medications Exclusion Criteria: * Secondary hypertension * Orthostatic hypotension * Proteinuria \>3 g/day * Serum potassium \>4.8 milliequivalents per liter (mEq/L)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 390, 'type': 'ESTIMATED'}}

2024-05-10