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NCT06865885 · ClinicalTrials.gov registry record · Phase 4
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
A Phase 4 study of Cardiometabolic Syndrome and Drug Interactions, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06865885 is a Phase 4 study of Cardiometabolic Syndrome and Drug Interactions that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 100 participants, below the 137-participant average among 9 other Cardiometabolic Syndrome trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06865885, a Phase 4 study of Cardiometabolic Syndrome and Drug Interactions, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Study Locations (1)
California
- UC San Diego Altman Clinical and Translational Research Institute - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-04-03 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06865885
The ClinicalTrials.gov registry entry for NCT06865885 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 137-participant average among 9 other Cardiometabolic Syndrome trials with a reported enrollment target (27% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Cardiometabolic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL is the first listed.
NCT06865885 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06865885 about?
NCT06865885 is a clinical study titled "LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering". 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...
What is the current status of trial NCT06865885?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-04-03. Estimated completion is 2026-12-31.
What conditions does trial NCT06865885 study?
This clinical trial studies the following conditions: Cardiometabolic Syndrome, Drug Interactions, Primary Prevention, LDL-Cholersterol Lowering.
What interventions are being tested in trial NCT06865885?
The interventions under investigation include: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL (DRUG).
Who is sponsoring clinical trial NCT06865885?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06865885 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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