Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

The Medicines Company

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.

Brief summary

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD 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 a multicenter study in the 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-10
status
COMPLETED
phase
PHASE3
study type
INTERVENTIONAL
enrollment
1561
sponsor
The Medicines Company
conditions
ASCVD; Elevated Cholesterol
interventions
DRUG: Inclisiran Sodium; DRUG: Placebo
start date
2017-12-21
start date type
ACTUAL
primary completion date
2019-09-10
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

Record

Archive ID
nct:NCT03399370
Published
Jan 16, 2018
Updated
Oct 5, 2020
Venue
ClinicalTrials.gov
ClinicalTrials.gov
NCT03399370
Categories
ASCVD, Elevated Cholesterol
License
ClinicalTrials.gov terms (attribution, processing date, modifications noted)
Provenance
clinicaltrials

Topics