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siRNA

Inclisiran for High Cholesterol (ORION-13 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Homozygous Familial Hypercholesterolemia (HoFH) diagnosed by genetic confirmation
Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after day 90 up to day 330
Awards & highlights

ORION-13 Trial Summary

This trial will test a new drug to see if it's safe and effective in reducing cholesterol in teens with a genetic condition that causes high cholesterol.

Who is the study for?
This trial is for adolescents with a genetic condition called homozygous familial hypercholesterolemia (HoFH) and high LDL cholesterol levels, despite being on the highest dose of statins they can tolerate. They should not have used certain other cholesterol drugs recently and must have decent kidney function.Check my eligibility
What is being tested?
The study tests Inclisiran, a new medication aimed at lowering LDL cholesterol, against a placebo in young people with severe inherited high cholesterol. It's designed to see if it's safe and effective in reducing their cholesterol levels.See study design
What are the potential side effects?
While specific side effects for Inclisiran are not listed here, common ones may include injection site reactions, allergic responses, liver enzyme changes, muscle pain or weakness, and potential interactions with other lipid-lowering therapies.

ORION-13 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been genetically diagnosed with Homozygous Familial Hypercholesterolemia.
Select...
My kidney function is above the minimum level required.

ORION-13 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after day 90 up to day 330
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after day 90 up to day 330 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Low-Density Lipoproteins
Secondary outcome measures
% change and absolute change in LDL-C from baseline up to Day 720
% change and absolute change in other lipoprotein and lipid parameters from baseline up to Day 720
% change and absolute change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline up to Day 720
+1 more

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

ORION-13 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InclisiranExperimental Treatment1 Intervention
Year 1 - inclisiran sodium 300 mg subcutaneous injection (given at Days 1, 90, and 270) Day 360 only - placebo subcutaneous injection Year 2 - inclisiran sodium 300 mg 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 300 mg 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
~2240

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,340 Total Patients Enrolled
18 Trials studying Hypercholesterolemia
12,273 Patients Enrolled for Hypercholesterolemia

Media Library

Inclisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT04659863 — Phase 3
Hypercholesterolemia Research Study Groups: Inclisiran, Placebo
Hypercholesterolemia Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT04659863 — Phase 3
Inclisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04659863 — Phase 3

Frequently Asked Questions

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

Who meets the basic requirements to take part in this research?

"The target patients for this study are those who suffer from hyperlipoproteinemia type ii and are between the ages of 12 to 17. So far, the study has recruited 12 individuals."

Answered by AI

What conditions has Inclisiran been shown to be effective in treating?

"Inclisiran is used to lower cholesterol levels in patients with primary hypercholesterolemia. Additionally, this medication can be employed to prevent atherosclerotic cardiovascular disease in those struggling with conditions like diet-induced hypercholesterolemia."

Answered by AI

What are the unique aspects of this research?

"Inclisiran's journey from initial research to Phase 3 approval spanned 2018. The first clinical trial, sponsored by Novartis Pharmaceuticals, involved 15000 patients. Post-trial, Inclisiran was approved for Phase 3 drug trials. Currently, there are 11 ongoing trials in 588 different cities and 52 countries worldwide."

Answered by AI

How many people are participating in this clinical trial?

"That is correct. Our research shows that this study, which was first advertised on February 16th 2021, is still looking for participants. They need 12 people in total and have 4 different sites where the trial is taking place."

Answered by AI

What is the FDA's current stance on Inclisiran?

"Inclisiran has received a 3 on our safety scale at Power. This is because it is currently in Phase 3 clinical trials, which suggests that while there is some data affirming its efficacy, there are multiple rounds of data supporting its safety."

Answered by AI

Can you tell us about any other research that has been conducted using Inclisiran?

"There are currently 11 clinical trials underway for Inclisiran. 10 of those studies are in the final Phase 3 stage. Most of the research locations for Inclisiran are based in Ciudad de Mexico, but there are a total of 1414 sites running trials for this treatment worldwide."

Answered by AI

Are there still positions open in this clinical trial for volunteers?

"Yes, this information is available on clinicaltrials.gov. The trial was posted on February 16th, 2021 and has been actively recruiting since then with the most recent edit being made on July 29th, 2022."

Answered by AI

Is this research only interested in participants who are older than 20?

"The age limit for this particular clinical trial is 12-17. Out of the 81 total trials, 14 are geared towards children and 67 are for adults over the age of 65."

Answered by AI
Recent research and studies
~3 spots leftby Apr 2025