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siRNA

Inclisiran for High Cholesterol (ORION-16 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

Heterozygous Familial Hypercholesterolemia (HeFH) diagnosed either by genetic testing or on phenotypic criteria

Fasting LDL-C >130 mg/dL (3.4 mmol/L) at screening

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

ORION-16 Trial Summary

This trial will study the effects of a new drug, inclisiran, on adolescents with a genetic condition that causes high cholesterol.

Who is the study for?

This trial is for adolescents with a condition called heterozygous familial hypercholesterolemia (HeFH) and high LDL cholesterol levels. They should be on the highest dose of statins they can handle, possibly with other cholesterol drugs, for at least 30 days before joining. Those with homozygous familial hypercholesterolemia, liver disease, secondary causes of high cholesterol like hypothyroidism or nephrotic syndrome, recent heart events, or previous PCSK9 inhibitor treatments cannot join.Check my eligibility

What is being tested?

The study tests Inclisiran's ability to lower bad cholesterol in teens with HeFH compared to a placebo. It's a phase III trial which means it’s checking if Inclisiran is safe and works well after earlier studies showed promise. Participants will randomly receive either Inclisiran or a dummy drug without knowing which one.See study design

What are the potential side effects?

Inclisiran could cause side effects such as injection site reactions (like pain or swelling), flu-like symptoms, muscle pain, headache and possible allergic reactions. The exact side effects in adolescents are being studied so there might be more that aren't known yet.

ORION-16 Trial Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with HeFH through genetic testing or based on symptoms.

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My fasting LDL cholesterol is above 130 mg/dL.

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My kidney function, measured by eGFR, is above 30.

ORION-16 Trial Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 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

Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 330

Secondary outcome measures

% change and absolute change in LDL-C from baseline up to Day 720

% change and absolute change in other lipoproteins 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

+3 more

Side effects data

From 2019 Phase 3 trial • 482 Patients • NCT03397121

12%

Nasopharyngitis

Injection site reaction

Upper respiratory tract infection

Back pain

Influenza

Acute myocardial infarction

Aortic valve stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Inclisiran

ORION-16 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,209 Total Patients Enrolled

18 Trials studying Hypercholesterolemia

12,142 Patients Enrolled for Hypercholesterolemia

Media Library

Inclisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT04652726 — Phase 3

Hypercholesterolemia Research Study Groups: Inclisiran, Placebo

Hypercholesterolemia Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT04652726 — Phase 3

Inclisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04652726 — Phase 3

Hypercholesterolemia Patient Testimony for trial: Trial Name: NCT04652726 — Phase 3

Frequently Asked Questions

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

Does this experimental treatment only apply to adults over the age of 30?

"This particular clinical trial is testing the medication on adolescents who are older than 12 but have not yet turned 17."

Answered by AI

At how many facilities can patients enroll in this research project?

"Currently, there are 23 locations where patients can enroll in this trial. Some of these sites are in Morristown, Madison and Lebanon. It is recommended that you pick a location near you to limit travel."

Answered by AI

Have other procedures like this been tried before?

"Inclisiran has had a long clinical history, with the first study being sponsored by Novartis Pharmaceuticals back in 2018. This initial study only involved 15000 patients, yet it was enough to grant Phase 3 approval for the drug. Now, there are 11 active trials being conducted in 587 different cities and 51 countries."

Answered by AI

How many study subjects are part of this research project?

"The listing on clinicaltrials.gov does show that this research is recruiting individuals who meet the eligibility criteria. The first posting was on 1/27/2021 with the latest update being on 11/2/2022. They are looking for 150 total participants from 23 different sites."

Answered by AI

What are some other investigations that have looked at Inclisiran?

"There are currently 11 Inclisiran clinical trials underway. 10 of these are Phase 3 trials. While the majority of these studies are based in Bayamon, Gauteng, there are a total of 1407 locations running these trials."

Answered by AI

Is there still room for more test subjects in this experiment?

"According to the latest information available on clinicaltrials.gov, this clinical trial is open for enrolment. The listing was first created on 1/27/2021, with the most recent update on 11/2/2022."

Answered by AI

What medical conditions does Inclisiran usually help alleviate?

"Inclisiran can help lower cholesterol for patients with primary hypercholesterolemia, as well as those that have high cholesterol due to their diet."

Answered by AI

What is the Inclisiran medication's official stance with the FDA?

"Inclisiran has received a 3 for safety from Power because it is a Phase 3 trial, meaning that, while there is some data supporting efficacy, multiple rounds of data have supported safety."

Answered by AI

Could I potentially join this research project?

"This research is looking for 150 teenagers, aged 12 to 17, that have hypercholesterolemia. Most importantly, potential candidates must meet the following prerequisites: They must be on the maximal dose of statin (as decided by their investigator) with or without other lipid-lowering medication; and this dose must have been stable for at least 30 days before screening."

Answered by AI