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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 May 2026

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At a glance

  • Drugs Zilebesiran (Primary)
  • Indications Hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms ZENITH; ZENITH CVOT
  • Sponsors Alnylam Pharmaceuticals

Most Recent Events

  • 20 Feb 2026 Planned End Date changed from 29 Oct 2030 to 30 Sep 2030.
  • 20 Feb 2026 Planned primary completion date changed from 29 Oct 2030 to 30 Sep 2030.
  • 01 Oct 2025 According to Alnylam media release, the company and its partner Roche will enroll approximately 11,000 patients in 35 countries to evaluate zilebesiran (300 mg) administered every six months compared to placebo.

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