Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

Brief summary

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

ORION-11

status

COMPLETED

phase

PHASE3

study type

INTERVENTIONAL

enrollment

1617

sponsor

The Medicines Company

conditions

ASCVD; Risk Factor, Cardiovascular; Elevated Cholesterol

interventions

DRUG: Inclisiran Sodium; DRUG: Placebo

start date

2017-11-01

start date type

ACTUAL

primary completion date

2019-07-31

has results

true

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters