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siRNA

Inclisiran for High Cholesterol (V-PEDS-OLE Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 in the study up to the end of study visit; up to 1080 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies the long-term safety and effectiveness of a drug for people with high cholesterol due to familial hypercholesterolemia.

Who is the study for?
This trial is for men and women who have a condition called HeFH or HoFH, which are types of high cholesterol, and have already been part of the ORION-16 or ORION-13 studies. They should have seen benefits from taking inclisiran previously without serious safety issues.
What is being tested?
The study is testing the long-term safety and how well people can tolerate inclisiran, a medication for lowering cholesterol levels in patients with HeFH or HoFH who completed prior related studies.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any long-term safety concerns and how well they can handle inclisiran over an extended period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 in the study up to the end of study visit; up to 1080 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 in the study up to the end of study visit; up to 1080 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Secondary study objectives
Percentage and absolute change in LDL-C from baseline in the feeder study to end of study

Side effects data

From 2019 Phase 3 trial • 482 Patients • NCT03397121
12%
Nasopharyngitis
9%
Injection site reaction
7%
Upper respiratory tract infection
7%
Back pain
5%
Influenza
1%
Acute myocardial infarction
1%
Aortic valve stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Inclisiran

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InclisiranExperimental Treatment1 Intervention
Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~2820

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,549 Total Patients Enrolled
24 Trials studying Hypercholesterolemia
29,311 Patients Enrolled for Hypercholesterolemia

Media Library

Inclisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT05682378 — Phase 3
Hypercholesterolemia Research Study Groups: Inclisiran
Hypercholesterolemia Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT05682378 — Phase 3
Inclisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05682378 — Phase 3
~103 spots leftby Jun 2028
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