LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering (NCT06865885)
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
🩺 Plain-English Summary (8th-Grade Level)
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. There is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (11 items).
Location: UC San Diego Altman Clinical and Translational Research Institute — La Jolla, California
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UC San Diego Altman Clinical and Translational Research Institute — La Jolla, California
📞 Contact the Study Coordinator
Phone: (858) 657-8530
Email: ptaub@health.ucsd.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.