Recruiting

Inclisiran

Sponsor:

UCLA

Code:

NCT06865885

Conditions

Drug Interactions

Primary Prevention

Cardiometabolic Syndrome

LDL-Cholersterol Lowering

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

Study Details

Brief summary:

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.

Conditions

Drug Interactions

Primary Prevention

Cardiometabolic Syndrome

LDL-Cholersterol Lowering

Study ID

NCT06865885

Start date

Apr 2, 2025

Status verified date

Jul, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care, no intervention

Patients will continue the standard of care for lipid lowering as deemed appropriate by their medical team, no changes to lipid lowering therapy are permited during the study.

active comparator: Inclisiran Arm

Patients in the intervention arm will be treated with a subcutaneous injection of inclisiran 284mg for three doses (baseline visit, 3 months, then 9 month visit) as add-on therapy to the standard of care for lipid lowering as determined by their medical team.

Interventions

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

The intervention arm will receive subcutaneous injection of inclisiran 284mg at the baseline visit, 3 months and 9 month visit.

Primary outcome measure

  • Change of LDL-Cholesterol [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Pam Taub, MD

858-657-8530ptaub@health.ucsd.edu

Antoinette S Birs, MD

5612817745abirs@health.ucsd.edu

Locations

UC San Diego Altman Clinical and Translational Research Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Marissa Dzotsi, MPH

858-534-8234mfdzotsi@health.ucsd.edu

Lauren Harris

858-246-2406lnharris@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Statin intolerance
  • drug drug interaction
  • inclisiran
  • LDL-Cholesterol
  • polypharmacy
  • multiple comorbidities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-07-13.