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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT05103332

Run by

Alnylam Pharmaceuticals

People needed

663

Starts

2021-11-05

Expected to finish

2024-09-13

Last updated by the study team

2025-11-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Office SBP at Screening as follows:
• ≥155 mmHg and ≤180 mmHg for patients with untreated hypertension
• ≥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

You may not qualify if…

• Secondary hypertension, orthostatic hypotension
• Elevated potassium <lower limit of normal (LLN) range or >5 milliequivalents per liter (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, or laboratory evidence of diabetes during screening without known diagnosis of diabetes
• History of any cardiovascular event within 6 months prior to randomization
• History of intolerance to SC injection(s)

Where it is running

• Clinical Trial Site — Edinburgh, United Kingdom
• Clinical Trial Site — Fowey, United Kingdom
• Clinical Trial Site — Glasgow, United Kingdom
• Clinical Trial Site — Mesa, Arizona, United States
• Clinical Trial Site — Tempe, Arizona, United States
• Clinical Trial Site — Tempe, Arizona, United States
• Clinical Trial Site — Bell Gardens, California, United States
• Clinical Trials Site — Beverly Hills, California, United States
• Clinical Trial Site — Canoga Park, California, United States
• Clinical Trial Site — Carlsbad, California, United States
• Clinical Trial Site — Encinitas, California, United States
• Clinical Trial Site — Garden Grove, California, United States
• Clinical Trial Site — Hollywood, California, United States
• Clinical Trial Site — Huntington Beach, California, United States
• Clinical Trial Site — Irvine, California, United States
• Clinical Trial Site — Long Beach, California, United States
• Clinical Trial Site — Los Angeles, California, United States
• Clinical Trial Site — Mission Hills, California, United States
• Clinical Trial Site — Oceanside, California, United States
• Clinical Trial Site — Panorama City, California, United States
• Clinical Trial Site — San Diego, California, United States
• Clinical Trial Site — Santa Clarita, California, United States
• Clinical Trial Site — South Gate, California, United States
• Clinical Trial Site — Tustin, California, United States
• Clinical Trial Site — Carshalton, United Kingdom

Full record on ClinicalTrials.gov

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