Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

Conditions

• High Cardiovascular Risk
• High Risk Cardiovascular Disease
• Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zilebesiran — DRUG
  Zilebesiran will be administered SC
• Placebo — DRUG
  Placebo will be administered SC

Study Details

The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.

Key Dates

Start date

Sep 22, 2025

Status verified

May 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

11,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zilebesiran 300 mg
  Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.
• Placebo Comparator: Placebo
  Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.

Primary Outcome Measure

Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit) [ Time Frame: Up to approximately 5 years ]

Central Contacts

• Clinical Trial Information Line
  1-877-ALNYLAM
  [email protected]
• Clinical Trial Information Line
  1-877-256-9526
  [email protected]

Locations (247)

Find similar trials in Birmingham, AL

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