Description
This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of plozasiran injection in approximately 1328 adult subjects with HTG. After informed consent, subjects will be assessed for eligibility during a screening period. Enrolled subjects will be counseled to remain on the specified low-fat diet and background medications throughout the study. Diet and lifestyle counseling should commence at the start of the screening period and continue to be reinforced throughout the study. Lipid parameters assessed during the screening period for eligibility and evaluated throughout the study will be collected from subjects in a fasted state. Safety will be assessed by monitoring/evaluation of treatment-emergent adverse events (TEAEs), adjudicated MACE, glycemic status, physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory tests. Immunogenicity will be assessed by incidence and titers of ADA to IMP. Study procedures are detailed in the Schedule of Assessments in the protocol.
