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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

No Placebo-Only Group

Pivotal Trial

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and feeder study baseline, orion-8 baseline, day 1080/eos (orion-8) (up to a maximum of 2340 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

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 more

Other 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 • NCT03399370

15%

Diabetes mellitus

Bronchitis

Hypertension

Back pain

Coronary artery disease

Acute myocardial infarction

Squamous cell carcinoma of skin

Syncope

Cardiac failure congestive

Angina pectoris

Angina unstable

Atrial fibrillation

Myocardial infarction

Cellulitis

Pneumonia

Non-cardiac chest pain

Sepsis

Prostate cancer

Cerebrovascular accident

Ischaemic stroke

Small intestinal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

Inclisiran

Saline Solution

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 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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