RECRUITING

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

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Conditions

Drug InteractionsPrimary PreventionCardiometabolic SyndromeLDL-Cholersterol LoweringStatin intolerancedrug drug interactioninclisiranLDL-Cholesterolpolypharmacymultiple comorbidities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-03
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06865885

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form.
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study, including potential randomization to injections.
  3. * Age \>18 and \<85 years and able to provide self-consent.
  4. * Taking five or more prescription drugs at the time of enrollment, of any type.
  5. * Meets at least one of the following criteria:
  6. * Elevated 10-year ASCVD risk score ≥7.5% (based on the ACC/AHA ASCVD Risk Estimator Plus tool).
  7. * Evidence of subclinical atherosclerosis including:
  8. * On maximally tolerated statin therapy (which can be no statin for patients with documented intolerance) and have suboptimal LDL levels:
  9. * For patients with Type II diabetes: LDL \>70 mg/dL or non-HDL \>120 mg/dL.
  10. * For other patients: LDL \>90 mg/dL or non-HDL \>120 mg/dL.
  11. * Willing to adhere to the randomized study regimen, including subcutaneous injection of inclisiran.
  12. * Agreement to adhere to lifestyle considerations (see Section 5.3) throughout the study duration.
  1. * Prior or current use of inclisiran.
  2. * Known hypersensitivity or allergy to inclisiran or its components.
  3. * Active liver disease or unexplained persistent elevations in liver enzymes (ALT or AST \>3x upper limit of normal).
  4. * History of rhabdomyolysis or severe muscle-related statin intolerance.
  5. * Uncontrolled diabetes (HbA1c \>8.5%).
  6. * Active malignancy requiring systemic therapy.
  7. * Recent major cardiovascular event (myocardial infarction, stroke, or hospitalization for unstable angina) within the past 3 months.
  8. * History of organ transplant other than solid-organ transplant.
  9. * Pregnancy or breastfeeding.
  10. * Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures.

Contacts and Locations

Study Contact

Pam Taub, MD
CONTACT
858-657-8530
ptaub@health.ucsd.edu
Antoinette S Birs, MD
CONTACT
5612817745
abirs@health.ucsd.edu

Principal Investigator

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

Study Locations (Sites)

UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-03
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-04-03
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Drug Interactions
  • Primary Prevention
  • Cardiometabolic Syndrome
  • LDL-Cholersterol Lowering