Optimizing LDL cholesterol levels using inclisiran for patients with drug interactions
Study of Optimal LDL-C Value Enhancement With Inclisiran in Patients With Multiple Comorbidities in Which There Are Drug-Drug Interactions Limiting LDL-C Lowering
This study is testing if inclisiran can help lower LDL cholesterol in patients with multiple health issues who can't take statins due to other medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06865885 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of inclisiran, a medication for lowering LDL cholesterol, in patients who are unable to optimize statin therapy due to drug-drug interactions. The study involves high-risk primary prevention patients with multiple comorbidities, such as Type II diabetes and chronic kidney disease, who are currently taking five or more prescription medications. Participants will be randomly assigned to receive inclisiran in addition to standard care or standard care alone, with LDL cholesterol levels monitored over a 12-month period. The trial aims to address the unmet need for effective LDL management in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 who are taking five or more prescription medications and have a high risk of cardiovascular disease.
Not a fit: Patients who are not on multiple medications or do not have elevated cardiovascular risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve LDL cholesterol levels and reduce cardiovascular risk in patients with complex medication regimens.
How similar studies have performed: Other studies have shown promising results with inclisiran for LDL lowering, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 hemodynamically significant. o Type II diabetes on a stable medical regimen with HbA1c \<8.5%. Per American Diabetes Association guidelines, patients with Type II diabetes aged 40-75 years should be on a moderate-intensity statin. Patients with documented partial or complete statin intolerance are eligible for enrollment. * 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 randomized study regimen, including subcutaneous injection of inclisiran. * Agreement to adhere to lifestyle considerations (see Section 5.3) throughout the study duration. Exclusion Criteria: * 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.
Where this trial is running
La Jolla, California
- UC San Diego Altman Clinical and Translational Research Institute — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Pam Taub, MD — University of California, San Diego
- Study coordinator: Pam Taub, MD
- Email: ptaub@health.ucsd.edu
- Phone: 858-657-8530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.