Inclisiran for High Cholesterol
(ORION-13 Trial)
Trial Summary
What is the purpose of this trial?
This trial tests inclisiran, a medication that lowers bad cholesterol, in adolescents with a genetic condition causing very high cholesterol. Inclisiran works by blocking a protein that increases cholesterol levels, leading to significant reductions in bad cholesterol.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you must be on a stable dose of statins or other lipid-lowering therapy for at least 30 days before joining. If you are taking certain medications like mipomersen or lomitapide, you need to stop them 5 months before screening.
How is the drug Inclisiran different from other treatments for high cholesterol?
Inclisiran is unique because it uses a small interfering RNA (siRNA) mechanism to lower cholesterol by targeting the PCSK9 protein, which is different from traditional statins that inhibit cholesterol production in the liver. It is administered as an injection every six months, offering a less frequent dosing schedule compared to daily oral medications.12345
Research Team
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Year 1)
Participants receive either inclisiran or placebo subcutaneous injections at Days 1, 90, and 270
Open-label Treatment (Year 2)
All participants receive inclisiran subcutaneous injections at Days 360, 450, and 630
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Inclisiran
- Placebo
Inclisiran is already approved in European Union, United States, China for the following indications:
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
- Heterozygous familial hypercholesterolemia (HeFH)
- Clinical atherosclerotic cardiovascular disease (ASCVD)
- Primary hypercholesterolemia
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD