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siRNA
Inclisiran Sodium for High Cholesterol (ORION-8 Trial)
Phase 3
Waitlist Available
Led By Scott Wright, MD
Research Sponsored by Novartis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up feeder study baseline, orion-8 baseline, day 1080/eos (orion-8) (up to a maximum of 2340 days)
Awards & highlights
Summary
This trial tested the use of Inclisiran, an injectable medication, in patients with high cholesterol that doesn't respond to other treatments. Inclisiran works by lowering a protein that increases cholesterol levels. The study aimed to see if it is safe and effective over a longer period. Inclisiran has shown about a 50% reduction in cholesterol levels with occasional use.
Eligible Conditions
- High Cholesterol
- Hypercholesterolemia
- Cardiovascular Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ feeder study baseline, orion-8 baseline, day 1080/eos (orion-8) (up to a maximum of 2340 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~feeder study baseline, orion-8 baseline, day 1080/eos (orion-8) (up to a maximum of 2340 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-emergent Adverse Events (TEAEs)
Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk
Secondary study objectives
Absolute Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C
Absolute Change in LDL-C From the Initial Feeder Study Baseline
Percentage Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C
+1 moreOther study objectives
Safety assessments including adverse events, serious adverse events, ECGs, concomitant medications, and safety laboratory parameters will be performed. The formation and further characterization of anti-drug antibodies will also be evaluated.
Side effects data
From 2019 Phase 3 trial • 1561 Patients • NCT0339937015%
Diabetes mellitus
6%
Bronchitis
5%
Hypertension
5%
Back pain
2%
Coronary artery disease
2%
Acute myocardial infarction
1%
Squamous cell carcinoma of skin
1%
Syncope
1%
Cardiac failure congestive
1%
Angina pectoris
1%
Angina unstable
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Cellulitis
1%
Pneumonia
1%
Non-cardiac chest pain
1%
Sepsis
1%
Prostate cancer
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Small intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Inclisiran
Saline Solution
Trial Design
1Treatment groups
Experimental Treatment
Group I: InclisiranExperimental Treatment1 Intervention
Inclisiran sodium 300 milligrams (mg) was administered as a single SC injection on Day 1\*, 90, then every 180 days to Day 990.
\*Subjects who received blinded placebo in the feeder study received blinded inclisiran and subjects who received blinded inclisiran in the feeder study received blinded placebo on Day 1 in ORION-8. Subjects from the open label ORION-3 study did not receive any injection of study drug on Day 1. Their first dose of study medication was at day 90
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran Sodium
2017
Completed Phase 3
~6460
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Who is running the clinical trial?
NovartisLead Sponsor
1,624 Previous Clinical Trials
2,720,507 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,198,729 Total Patients Enrolled
3 Trials studying High Cholesterol
15,080 Patients Enrolled for High Cholesterol
Scott Wright, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
1,561 Total Patients Enrolled
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