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Anti-sense Oligonucleotide
Inclisiran for Hypercholesterolemia (ORION-20 Trial)
Kuala Lumpur, Malaysia
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
Male or female participants, 6 to <12 years of age at screening
HeFH diagnosed either by genetic testing or on phenotypic criteria
Must not have
Previous treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9
Homozygous familial hypercholesterolemia (HoFH)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after day 90 up to day 330
Awards & highlights
Pivotal Trial
Summary
This trial will test the safety, side effects, and effectiveness of a medication called inclisiran in children between the ages of 6 and 12 with a specific type of high cholesterol called heterozy
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Who is the study for?
This trial is for children aged 6 to under 12 with heterozygous familial hypercholesterolemia (HeFH) and high LDL cholesterol levels. They must be on a stable dose of lipid-lowering treatments like statins or ezetimibe for at least 30 days before the study, with no changes expected during the trial.Check my eligibility
What is being tested?
The study tests Inclisiran's safety and effectiveness in lowering bad cholesterol compared to a placebo in kids with HeFH. It's a phase III trial where participants are randomly assigned to receive either Inclisiran or an inactive substance.See study design
What are the potential side effects?
Inclisiran may cause side effects such as injection site reactions, flu-like symptoms, headache, muscle pain, and potential liver enzyme elevations. The exact side effects in children will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 11 years old.
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I have been diagnosed with HeFH through genetic tests or based on symptoms.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken PCSK9 inhibitor drugs in the last 90 days.
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I have been diagnosed with Homozygous Familial Hypercholesterolemia.
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My body weight is less than 16 kg.
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I do not have active liver disease or unexplained high liver enzyme levels.
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I am not pregnant or nursing.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, after day 90 up to day 330
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after day 90 up to day 330
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage change in LDL-C from baseline to Day 330 (Year 1)
Secondary study objectives
Absolute change in Apo B, Apo A1 from baseline to each assessment time up to Day 720 (Year 2)
Absolute change in LDL-C from baseline to Day 330 (Year 1)
Absolute change in LDLC, total cholesterol, non-HDLC, triglycerides, HDL-C, VLDL-C from baseline to each assessment time up to Day 720 (Year 2)
+10 moreSide effects data
From 2019 Phase 3 trial • 482 Patients • NCT0339712112%
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
Inclisiran
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InclisiranExperimental Treatment1 Intervention
Year 1 - inclisiran sodium subcutaneous injection (given at Days 1, 90, and 270) Day 360 only - placebo subcutaneous injection Year 2 - inclisiran sodium subcutaneous injection (given at Days 450 and 630)
Group II: PlaceboPlacebo Group1 Intervention
Year 1 - placebo subcutaneous injection (given at Days 1, 90 and 270) Year 2 - inclisiran sodium subcutaneous injection (given at Days 360, 450, and 630)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~3580
Find a Location
Closest Location:Excel Medical Clinical Trials LLC· Boca Raton, FL
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,959 Previous Clinical Trials
4,274,183 Total Patients Enrolled
25 Trials studying Hypercholesterolemia
29,688 Patients Enrolled for Hypercholesterolemia