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Inclisiran for LDL-C Optimization in Patients with Drug Interactions

This study is testing inclisiran (a medication given by injection) to help lower "bad" cholesterol (LDL-C) in people who are taking many other medications. Often, these other medications can make it hard to use standard cholesterol-lowering drugs like statins effectively. The study aims to see how much inclisiran can lower LDL-C over 12 months in these patients. You might be able to join if you are between 18 and 85 years old, take five or more prescription drugs, and have certain risk factors for heart disease. The study is currently unclear on its recruitment status, but plans to enroll up to 100 participants.

Study design
This is an open-label, randomized study involving up to 100 participants. Participants will be assigned to either receive inclisiran injections plus standard care or standard care alone.
What's involved
You would have five study visits over 12 months, including screening, baseline, 3 months, 9 months, and 12 months. These visits will involve medical history, medication review, and blood tests.
Compensation
Not stated in the trial record.
Follow-up
Your LDL-C levels will be measured at 12 months, which is the end of the study period.

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NCT06865885

LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering

Recruiting
PHASE4Ages 18–85InterventionalTreatment
University of California, San Diego
~100 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of LDL-Cholesterol
Measured over 12 months

Conditions

Drug Interactions
Primary Prevention
Cardiometabolic Syndrome
LDL-Cholersterol Lowering

Explore related trials

Cardiovascular DisorderStatin IntoleranceType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Michael Wilkinson, MD · STUDY_DIRECTOR · University of California, San Diego
  • Eric D Adler, MD · STUDY_CHAIR · University of California, San Diego
  • Pam Taub, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego
  • Antoinette Birs, MD · STUDY_DIRECTOR · University of California, San Diego

Who to contact

Pam Taub, MD
[email protected]
858-657-8530
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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.

What this trial measures

  • Change of LDL-Cholesterol12 months

    Percent Change in LDL-C from baseline to month 12 of treatment with inclisiran as add on to background lipid-lowering therapy that includes maximally tolerated statin.