CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 382 enrolled
Drug / intervention
Inclisiran +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03060577
NCT03060577Phase 2Completed
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An Open Label, Active Comparator Extension Trial to Assess the Effect of Long Term Dosing of Inclisiran and Evolocumab Given as Subcutaneous Injections in Participants With High Cardiovascular Risk and Elevated LDL-C (ORION-3)

Novartis Pharmaceuticals·interventional·Posted Feb 23, 2017·Updated Mar 24, 2023

In Brief

A Phase 2 clinical trial evaluating Inclisiran and Evolocumab for Atherosclerotic Cardiovascular Disease and 3 related conditions. Completed, enrolled 382 participants across 52 sites in 5 countries.

Detailed Summary

This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis, Type2 Diabetes, Familial Hypercholesterolemia
CountriesCanada, Germany, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartApr 27, 2017
Primary CompletionDec 17, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 9.4 years ago

Interventions

Inclisirandrug

Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.

Evolocumabdrug

Evolocumab is a fully human monoclonal antibody that inhibits PCSK9.