Phase 3Recruiting
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease (ZENITH)
ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
- Sponsor
- Alnylam Pharmaceuticals (Industry)
- Enrolment
- 11,000 planned
- Conditions
- High Risk Cardiovascular Disease; Hypertension; High Cardiovascular Risk
- Interventions
- Zilebesiran; Placebo
- Ages
- adults, older adults
- Registry
- NCT07181109, CTIS2025-522960-34-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- 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)
History
Primary completion expected
Last registry update
Registered
Started