Drug Interactions study: Inclisiran sodium
Official title LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
ClinicalTrials.gov ID: NCT06865885
What this study is testing
What is Inclisiran sodium 300 mg?
This is an investigational injectable medicine being studied to help lower LDL cholesterol in patients who cannot take higher doses of statins due to other medications. It is designed to block the production of a protein in the liver that helps make LDL cholesterol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding inclisiran to usual care can lower LDL cholesterol in high‑risk patients who cannot use statins because of drug interactions.
- Who it's for
- Adults with high cardiovascular risk, multiple health conditions (like diabetes, liver or kidney disease, autoimmune disease, or organ transplant) who are on five or more medications that interfere with statins.
- What's involved
- Participants will receive subcutaneous injections of inclisiran and continue their regular medications. They will have clinic visits and blood tests to monitor cholesterol and safety.
- Time commitment
- The trial lasts about 12 months, with regular clinic visits and blood draws throughout the study period.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Provide signed and dated informed consent form.
- Are willing to comply with all study procedures and availability for the duration of the study including the potential randomization to injections...
- Are ≥ 18 and ≤ 85 years of age with the ability to consent for themselves.
- Take 5 or more medications at the time of enrollment (any type of medication).
- Elevated 10-year ASCVD risk score ≥7.5% based on the ACC/AHA Pooled Cohort ASCVD Risk Estimator Plus tool OR PREVENT-ASCVD 10-Year Risk Estimate ≥...
You likely can't join if
- Have a history of ASCVD, defined as history of myocardial infarction, atherosclerotic ischemic stroke, transient ischemic attack (TIA) of...
- For heart transplant recipients, history of myocardial infarction, CABG, or coronary artery stenting is only exclusionary after most recent heart...
- Non-atherosclerotic ischemic strokes or TIAs identified as cardioembolic or attributed to hypercoagulability or non-atherosclerotic vasculopathy are...
- Are pregnant, nursing, or trying to conceive.
- Are currently taking PCSK9 inhibitors (evolocumab, alirocumab) or are already on inclisiran.
- Have a coronary artery calcium score ≥ 300 as these patients are considered secondary prevention patients.
See the full eligibility criteria
- Provide signed and dated informed consent form.
- Are willing to comply with all study procedures and availability for the duration of the study including the potential randomization to injections, as stated by the participant and assessed by study staff.
- Are ≥ 18 and ≤ 85 years of age with the ability to consent for themselves.
- Take 5 or more medications at the time of enrollment (any type of medication). This includes prescription drugs, as well as over-the-counter drugs or supplements recommended by a healthcare provider, in line with the...
- Elevated 10-year ASCVD risk score ≥7.5% based on the ACC/AHA Pooled Cohort ASCVD Risk Estimator Plus tool OR PREVENT-ASCVD 10-Year Risk Estimate ≥ 10%...
- calcification in any vascular bed, including coronary arteries, aorta
- calcification of cardiac valves
- breast calcification
- carotid plaque that is not hemodynamically significant Or
- Type II diabetes with HbA1c less than 8.5.
- Take maximally tolerated dose of statin therapy (for patients that have documented statin intolerance or contraindication, this can be no statin) and have suboptimal LDL levels (LDL ≥ 70 mg/dL or non-HDL ≥ 100 mg/dL...
- Are on stable lipid-lowering therapy for at least 4 weeks prior to screening. Patients can also take other non-PCSK9i lipid-lowering therapies, such as ezetimibe, bempedoic acid, icosapent ethyl, and fibrates.
- May have potential drug-drug interactions that may limit statin dose or up-titration.
- Agree to adhere to lifestyle considerations (see Section 5.3) throughout study duration.
- Have a history of ASCVD, defined as history of myocardial infarction, atherosclerotic ischemic stroke, transient ischemic attack (TIA) of atherosclerotic ischemic origin, coronary artery bypass graft (CABG)...
- For heart transplant recipients, history of myocardial infarction, CABG, or coronary artery stenting is only exclusionary after most recent heart transplant.
- Non-atherosclerotic ischemic strokes or TIAs identified as cardioembolic or attributed to hypercoagulability or non-atherosclerotic vasculopathy are NOT exclusionary.
- Are pregnant, nursing, or trying to conceive.
- Are currently taking PCSK9 inhibitors (evolocumab, alirocumab) or are already on inclisiran. If any prior exposure to evolocumab or alirocumab, the last dose should have been at least 12 weeks prior to study enrollment.
- Have a coronary artery calcium score ≥ 300 as these patients are considered secondary prevention patients.
- Are currently enrolled in medical research judged not to be scientifically or medically compatible with this study as determined at the discretion of the PI.
- Have any other medical condition(s) or take any treatment(s) deemed by the investigator to pose a risk to patient safety or interfere with study evaluation, procedures, or completion.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.