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

Clinical trial · The Medicines Company

- Archive id: nct:NCT03400800
- Published: 2018-01-17
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03400800
- Source URL: https://clinicaltrials.gov/study/NCT03400800
- Provenance: clinicaltrials

## Abstract

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).

_Abstract reproduced under 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._

## 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

Topics: [Cardiovascular Therapeutics](https://space-kitty.com/topics/cardiovascular-innovation)

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