6,000
Participants
Start Date
July 23, 2025
Primary Completion Date
October 31, 2029
Study Completion Date
December 31, 2029
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \& every 6 months thereafter
Normal Saline (Placebo)
Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter
RECRUITING
Duke Cardiology, Morrisville
RECRUITING
PharmaTex Research, Amarillo
RECRUITING
Pacific Oaks Medical Group, Beverly Hills
RECRUITING
Radin Cardiovascular Medical Group, Inc, Newport Beach
RECRUITING
Advanced Heart Care LLC, Bridgewater
Lead Sponsor
Collaborators (1)
Novartis Pharmaceuticals
INDUSTRY
Colorado Prevention Center
OTHER
Mount Sinai Hospital, New York
OTHER
Duke University
OTHER