NCT03060577

An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

MDCO-PCS-16-01 (ORION-3) was a Phase II, open-label, multicenter, non-randomized, active comparator long term extension study. Total study duration was 4 years from first participant enrolled to the last subject completed. The study consisted of three study periods: Screening Period: Participants completing study MDCO-PCS-15-01 (ORION-1) were screened for all inclusion and exclusion criteria of study ORION-3. Treatment Period: Participants fulfilling all eligibility criteria of ORION-3 were enrolled. Participants who received inclisiran in ORION-1 received inclisiran sodium throughout this study up to 4 years (Group 1; Inclisiran-only arm), and participants who received placebo in ORION-1 received evolocumab as open-label comparator up to Day 336, and then transitioned to inclisiran on Day 360 and every 180 days thereafter for up to 4 years (Group 2; Switching arm). Safety follow up: Participants were followed up for safety during 4 weeks after the last dose of study treatment. Including the Screening Period, the total study duration for a participant was up to 4 years.

Conditions

• Atherosclerotic Cardiovascular Disease
• Symptomatic Atherosclerosis
• Type2 Diabetes
• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Inclisiran	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.
DRUG	Evolocumab	Evolocumab is a fully human monoclonal antibody that inhibits PCSK9.

Timeline

• Start date: 2017-04-27
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2017-02-23
• Last updated: 2023-03-24
• Results posted: 2023-03-24

Locations

52 sites across 5 countries: United States, Canada, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study