RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-10-24
Study Completion:2030-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07181109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is 18 years or older for patients with established cardiovascular disease (CVD)
  2. * Is 55 years or older for patients with high risk for CVD
  3. * Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
  4. * Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
  1. * Has known history of secondary hypertension
  2. * Has symptomatic orthostatic hypotension
  3. * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN)
  4. * Has total serum bilirubin \>1.5×ULN
  5. * Has international normalized ratio (INR) \>1.5
  6. * Has serum potassium \>4.8 mEq/L
  7. * Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2

Contacts and Locations

Study Contact

Clinical Trial Information Line
CONTACT
1-877-ALNYLAM
clinicaltrials@alnylam.com
Clinical Trial Information Line
CONTACT
1-877-256-9526
clinicaltrials@alnylam.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Alnylam Pharmaceuticals Inc

Study Locations (Sites)

Clinical Trial Site
Mesquite, Texas, 75149u
United States

Collaborators and Investigators

Sponsor: Alnylam Pharmaceuticals

  • Medical Director, STUDY_DIRECTOR, Alnylam Pharmaceuticals Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10-24
Study Completion Date2030-10-29

Study Record Updates

Study Start Date2025-10-24
Study Completion Date2030-10-29

Terms related to this study

Keywords Provided by Researchers

  • High blood pressure
  • siRNA
  • Angiotensinogen
  • AGT
  • Cardiovascular disease
  • Uncontrolled hypertension
  • RNAi

Additional Relevant MeSH Terms

  • High Risk Cardiovascular Disease
  • Hypertension
  • High Cardiovascular Risk