Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL for Drug Interactions

Polypharmacy and drug-drug interactions often limit statin optimization, including in a population of patients prescribed cytochrome P3A4 inhibitors such as, 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.

Official registry: https://clinicaltrials.gov/study/NCT06865885 · University of California, San Diego · enrollment listed as 100

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL. The registry lists allocation as randomized. Polypharmacy and drug-drug interactions often limit statin optimization, including in a population of patients prescribed cytochrome P3A4 inhibitors such as, immunosuppressive agents, protease inhibitors, and antifungals.

They plan to enroll about 100 people at La Jolla. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

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

Primary outcome (registry wording): Change of LDL-Cholesterol

Who it is for (from inclusion criteria)

  • Ages 18 Years to 85 Years
  • To be eligible to participate in this study, individuals must meet all of the following criteria:
  • Are ≥ 18 and ≤ 85 years of age with the ability to consent for themselves
  • Take 5 or more medications at the time of enrollment (any type of medication). This includes prescription drugs, as well as over-the-counter drugs or supplements recommended by a healthcare provider, in line with the WHO definition of polypharmacy
  • Meet at least one of criteria a, b, or c:
  • Elevated 10-year ASCVD risk score ≥7.5% based on the ACC/AHA Pooled Cohort ASCVD Risk Estimator Plus tool OR PREVENT-ASCVD 10-Year Risk Estimate ≥ 10% (https://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) Or
  • Evidence of subclinical atherosclerosis:
  • calcification in any vascular bed, including coronary arteries, aorta

Public study contact (from the registry)

Pam Taub, MD

858-657-8530

ptaub@health.ucsd.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06865885 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06865885?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06865885?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary