Actively Recruiting
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Led by University of California, San Diego · Updated on 2025-04-11
100
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to comply with all study procedures and available for the study duration.
- Age greater than 18 and less than 85 years and able to provide self-consent.
- Taking five or more prescription drugs at enrollment.
- Meets at least one: Elevated 10-year ASCVD risk score ≥7.5%, evidence of subclinical atherosclerosis, or Type II diabetes on stable regimen with HbA1c <8.5%.
- Patients with documented partial or complete statin intolerance are eligible.
- On maximally tolerated statin therapy or no statin if intolerant, with suboptimal LDL levels (LDL >70 mg/dL for Type II diabetes or >90 mg/dL for others).
- Willing to adhere to randomized study regimen including subcutaneous inclisiran injection.
- Agree to follow lifestyle considerations throughout the study.
You will not qualify if you...
- Prior or current use of inclisiran.
- Known allergy to inclisiran or its components.
- Active liver disease or persistent liver enzyme elevations (ALT or AST >3x upper limit).
- History of rhabdomyolysis or severe muscle-related statin intolerance.
- Uncontrolled diabetes (HbA1c >8.5%).
- Active cancer requiring systemic therapy.
- Major cardiovascular event (heart attack, stroke, unstable angina hospitalization) within past 3 months.
- History of organ transplant other than solid-organ transplant.
- Pregnancy or breastfeeding.
- Any condition making participation unsafe or interfering with study procedures.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
P
Pam Taub, MD
CONTACT
A
Antoinette S Birs, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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