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New treatment option for Drug Interactions
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 (equivalent to 284 mg inclisiran) in 1.5 mL?
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for drug interactions.
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
- Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk.
- 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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study, including potential randomization to...
- Age \>18 and \<85 years and able to provide self-consent.
- Taking five or more prescription drugs at the time of enrollment, of any type.
- Meets at least one of the following criteria:
You likely can't join if
- Prior or current use of inclisiran.
- Known hypersensitivity or allergy to inclisiran or its components.
- Active liver disease or unexplained persistent elevations in liver enzymes (ALT or AST \>3x upper limit of normal).
- History of rhabdomyolysis or severe muscle-related statin intolerance.
- Uncontrolled diabetes (HbA1c \>8.5%).
- Active malignancy requiring systemic therapy.
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study, including potential randomization to injections.
- Age \>18 and \<85 years and able to provide self-consent.
- Taking five or more prescription drugs at the time of enrollment, of any type.
- Meets at least one of the following criteria:
- Elevated 10-year ASCVD risk score ≥7.5% (based on the ACC/AHA ASCVD Risk Estimator Plus tool).
- Evidence of subclinical atherosclerosis including: Calcification in any vascular bed, including coronary arteries and aorta. Calcification of cardiac valves. Breast calcification. Carotid plaque that is not...
- On maximally tolerated statin therapy (which can be no statin for patients with documented intolerance) and have suboptimal LDL levels:
- For patients with Type II diabetes: LDL \>70 mg/dL or non-HDL \>120 mg/dL.
- For other patients: LDL \>90 mg/dL or non-HDL \>120 mg/dL.
- Willing to adhere to the assigned by chance study regimen, including subcutaneous injection of inclisiran.
- Agreement to adhere to lifestyle considerations (see Section 5.3) throughout the study duration.
- Prior or current use of inclisiran.
- Known hypersensitivity or allergy to inclisiran or its components.
- Active liver disease or unexplained persistent elevations in liver enzymes (ALT or AST \>3x upper limit of normal).
- History of rhabdomyolysis or severe muscle-related statin intolerance.
- Uncontrolled diabetes (HbA1c \>8.5%).
- Active malignancy requiring systemic therapy.
- Recent major cardiovascular event (myocardial infarction, stroke, or hospitalization for unstable angina) within the past 3 months.
- History of organ transplant other than solid-organ transplant.
- Pregnancy or breastfeeding.
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.