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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
Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.
On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous study with no planned medication or dose change during study participation.
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

ORION-8 Trial Summary

This trial will study the long-term effects of Inclisiran, a drug used to treat high cholesterol. The trial will be conducted at multiple centers around the world.

Eligible Conditions
  • High Cholesterol
  • Hypercholesterolemia
  • Cardiovascular Disease

ORION-8 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ORION-8 Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-emergent Adverse Events (TEAEs)
Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk
Secondary outcome measures
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 outcome measures
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
6%
Bronchitis
5%
Back pain
5%
Hypertension
2%
Acute myocardial infarction
2%
Coronary artery disease
1%
Myocardial infarction
1%
Sepsis
1%
Angina pectoris
1%
Cellulitis
1%
Squamous cell carcinoma of skin
1%
Pneumonia
1%
Angina unstable
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Small intestinal obstruction
1%
Non-cardiac chest pain
1%
Prostate cancer
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Inclisiran
Saline Solution

ORION-8 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

Find a Location

Who is running the clinical trial?

NovartisLead Sponsor
1,608 Previous Clinical Trials
2,714,516 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,194,303 Total Patients Enrolled
2 Trials studying High Cholesterol
14,560 Patients Enrolled for High Cholesterol
Scott Wright, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
1,561 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other ongoing research projects that utilize Inclisiran Sodium?

"There are 11 ongoing trials for Inclisiran Sodium, with the majority of them being Phase 3 trials. The trials are being conducted in 1407 locations, with the most Inclisiran Sodium trials taking place in Bayamon and Gauteng."

Answered by AI

Does Inclisiran Sodium have FDA backing?

"Given that this is a Phase 3 trial with some data supporting efficacy and multiple rounds of data supporting safety, Inclisiran Sodium is estimated to be a 3 on Power's Safety Scale."

Answered by AI

What are some of the conditions that Inclisiran Sodium is regularly used to treat?

"Inclisiran Sodium is used to lower cholesterol levels in patients with primary hypercholesterolemia. It can also help those with diet-related hypercholesterolemia and atherosclerotic cardiovascular diseases."

Answered by AI

Are there any more positions available for patients in this experiment?

"This specific trial is not looking for patients at this moment, however, according to the latest information from clinicaltrials.gov, which was last updated on January 26th, 2022, this could change in the future. Additionally, there are 86 other studies that are actively recruiting patients."

Answered by AI

What are some other examples of this type of clinical research?

"Inclisiran Sodium has been researched since 2018. The initial trial was conducted in 2018 and was sponsored by Novartis Pharmaceuticals. Following the first trial in 2018, which involved 15000, Inclisiran Sodium received its Phase 3 drug approval. Today there are 11 live studied for Inclisiran Sodium across 587 cities and 51 countries."

Answered by AI

How many people are a part of this clinical study?

"This study is not recruiting at this moment. The listing was initially posted on 2019-04-16 and was updated on 2022-01-26. There are presently 75 studies actively admitting patients with ascvd and 11 trials for Inclisiran Sodium actively enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
Georgia
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~554 spots leftby Mar 2025