Study 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.
- Familial Hypercholesterolemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Baseline, after Day 90 up to Day 330
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
Inclisiran
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
13 Total Participants · 2 Treatment Groups
Primary Treatment: Inclisiran · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 12 - 17 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Warden, Bruce A., and Paul Barton Duell. 2021. “Inclisiran: A Novel Agent for Lowering Apolipoprotein B–containing Lipoproteins”. Journal of Cardiovascular Pharmacology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/fjc.0000000000001053.
- Reijman, M Doortje, Anja Schweizer, Amy L H Peterson, Eric Bruckert, Christian Stratz, Joep C Defesche, Robert A Hegele, and Albert Wiegman. 2022. “Rationale and Design of Two Trials Assessing the Efficacy, Safety, and Tolerability of Inclisiran in Adolescents with Homozygous and Heterozygous Familial Hypercholesterolaemia”. European Journal of Preventive Cardiology. Oxford University Press (OUP). doi:10.1093/eurjpc/zwac025.
- Warden, Bruce A., and Paul Barton Duell. 2021. “Inclisiran: A Novel Agent for Lowering Apolipoprotein B–containing Lipoproteins”. Journal of Cardiovascular Pharmacology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/fjc.0000000000001053.
- Reijman, M Doortje, Anja Schweizer, Amy L H Peterson, Eric Bruckert, Christian Stratz, Joep C Defesche, Robert A Hegele, and Albert Wiegman. 2022. “Rationale and Design of Two Trials Assessing the Efficacy, Safety, and Tolerability of Inclisiran in Adolescents with Homozygous and Heterozygous Familial Hypercholesterolaemia”. European Journal of Preventive Cardiology. Oxford University Press (OUP). doi:10.1093/eurjpc/zwac025.
- 2021. "Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04659863.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor