Your session is about to expire
← Back to Search
Inclisiran for High Cholesterol (ORION-13 Trial)
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.
ORION-13 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowORION-13 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 482 Patients • NCT03397121ORION-13 Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My tests show a negative mutation in both LDLR genes.I have not taken mipomersen or lomitapide in the last 5 months.I have been genetically diagnosed with Homozygous Familial Hypercholesterolemia.I have an ongoing liver condition.I have not taken PCSK9 inhibitors in the last 90 days.I have high cholesterol due to another health condition like thyroid issues or kidney problems.Your cholesterol level is too high when you haven't eaten for a while.I have not had a major heart problem in the last month.I have been on the highest dose of statin I can tolerate for at least 30 days.My kidney function is above the minimum level required.I have a genetic condition that causes high cholesterol.
- Group 1: Inclisiran
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
Share this study with friends
Copy Link
Messenger