LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Drug Interactions · Primary Prevention · Cardiometabolic Syndrome · LDL-Cholersterol Lowering · Polypharmacy
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 4
- Rango de edad
- 18 años - 85 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 100 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
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, etc.) who are taking five or more medications in which drug-drug interactions may prevent optimization of statin therapy.
Leer la descripción completa
This is an investigator-initiated, single-site, open-label, randomized trial. The investigators will enroll up to 100 high-risk primary prevention patients with at least one comorbidity and an indication for additional lipid control (such as Type II diabetes with A1c ≤ 8.5%, subclinical atherosclerosis, or increased 10-year ASCVD risk). Patients will be randomized 1:1 to the inclisiran arm (n ≥ 50) with standard of care or standard of care alone (n ≥ 50).
The study will consist of five study visits (screening, baseline, 3 months, 9 months, and 12 months). Patients in the inclisiran arm will receive a subcutaneous injection of inclisiran 284 mg for three doses (baseline, 3 months, and 9 months following randomization) as add-on therapy. LDL-C (the primary endpoint) along with other biomarkers will be measured at screening, baseline (inclisiran dose #1), 3 months (inclisiran dose #2), 9 months (inclisiran dose #3), and 12 months (labs only). Patients will also undergo medical history and medication review at each visit. Surveys will be completed at each visit during the study period.
Patients in the control arm (standard of care) will continue with their current lipid-lowering therapy. No adjustments will be made to lipid-lowering therapy during the course of the study. Participants will be aware of the group to which they have been randomized.
The primary objective is to determine the efficacy of inclisiran for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., type II diabetes, autoimmune disease, liver disease, chronic kidney disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions may prevent optimization of statin therapy.
¿Quién podría participar?
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Inclusion Criteria:
To be eligible to participate in this study, individuals must meet all of the following criteria:
1. Provide signed and dated informed consent form.
2. Are willing to comply with all study procedures and availability for the duration of the study including the potential randomization to injections, as stated by the participant and assessed by study staff.
3. Are ≥ 18 and ≤ 85 years of age with the ability to consent for themselves.
4. 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.
5. Meet at least one of criteria a, b, or c:
1. 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
2. Evidence of subclinical atherosclerosis:
* calcification in any vascular bed, including coronary arteries, aorta
* calcification of cardiac valves
* breast calcification
* carotid plaque that is not hemodynamically significant Or
3. Type II diabetes with HbA1c less than 8.5.
6. Take maximally tolerated dose of statin therapy (for patients that have documented statin intolerance or contraindication, this can be no statin) and have suboptimal LDL levels (LDL ≥ 70 mg/dL or non-HDL ≥ 100 mg/dL based on current treatment guidelines).
7. Are on stable lipid-lowering therapy for at least 4 weeks prior to screening. Patients can also take other non-PCSK9i lipid-lowering therapies, such as ezetimibe, bempedoic acid, icosapent ethyl, and fibrates.
8. May have potential drug-drug interactions that may limit statin dose or up-titration.
9. Agree to adhere to lifestyle considerations (see Section 5.3) throughout study duration.
Exclusion Criteria:
Individuals who meet any of the following criteria will be excluded from participation in this study:
1. Have a history of ASCVD, defined as history of myocardial infarction, atherosclerotic ischemic stroke, transient ischemic attack (TIA) of atherosclerotic ischemic origin, coronary artery bypass graft (CABG), coronary/carotid/peripheral artery/aortic stent for atherosclerotic disease, or peripheral artery disease diagnosed via imaging or ankle-brachial index).
* For heart transplant recipients, history of myocardial infarction, CABG, or coronary artery stenting is only exclusionary after most recent heart transplant.
* Non-atherosclerotic ischemic strokes or TIAs identified as cardioembolic or attributed to hypercoagulability or non-atherosclerotic vasculopathy are NOT exclusionary.
2. Are pregnant, nursing, or trying to conceive.
3. Are currently taking PCSK9 inhibitors (evolocumab, alirocumab) or are already on inclisiran. If any prior exposure to evolocumab or alirocumab, the last dose should have been at least 12 weeks prior to study enrollment. If any prior exposure to inclisiran, the last dose should have been at least 6 months prior to study enrollment.
4. Have a coronary artery calcium score ≥ 300 as these patients are considered secondary prevention patients.
5. Are currently enrolled in medical research judged not to be scientifically or medically compatible with this study as determined at the discretion of the PI.
6. Have any other medical condition(s) or take any treatment(s) deemed by the investigator to pose a risk to patient safety or interfere with study evaluation, procedures, or completion.
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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 permitted during the study.
Inclisiran Arm
Patients in the intervention arm will be treated with a subcutaneous injection of inclisiran 284mg for three doses (baseline visit, 3 month, then 9 month visit) as add-on therapy to the standard of care for lipid lowering as determined by their medical team.
Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL DRUG
The intervention arm will receive subcutaneous injection of inclisiran 284mg at the baseline visit, 3 month and 9 month visit.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change of LDL-Cholesterol
Plazo: 12 months
Percent Change in LDL-C from baseline to month 12 of treatment with inclisiran as add on to background lipid-lowering therapy that includes maximally tolerated statin.
Medidas secundarias
Change in Atherogenic Lipid Burden
Plazo: 12 months
Absolute and percent change in LDL particle number, apo B, non-HDL, and small LDL particle number, lipoprotein(a), from baseline (Day 1) to month 12 of treatment with inclisiran
Otras medidas
Patient-Reported Experience
Plazo: 12 months
Patient-reported outcomes and experiences determined by surveys at each visit (the Standardized Treatment Satisfaction Questionnaire for Medication and study-specific inclisiran satisfaction questionnaire).
Incidence of Adverse Events
Plazo: 12 months
Incidence of adverse events occurring during treatment with inclisiran.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
UC San Diego Altman Clinical and Translational Research InstituteLa Jolla, California, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- University of California, San Diego
- Inicio del estudio
- 2 abr 2025 Real
- Finalización primaria
- 1 jun 2028 Estimado
- Finalización del estudio
- 1 sept 2028 Estimado
- Primera publicación
- 10 mar 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026