An observational study in Primary Hypercholesterolemia and Mixed Dyslipidemia, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 38 sites in 8 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Novartis Pharmaceuticals · Observational
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.
Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)
Exclusion Criteria:
Participants prescribed inclisiran alone or with other LLTs as per approved label
Other: Inclisiran
Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.
Percentage change in LDL-C from baseline to 10 months
Percentage change in Low density lipoprotein - Cholesterol (LDL-C)
Time frame: Baseline, 10 months
Percentage change in LDL-C from baseline
Percentage change in LDL-C from baseline is collected
Time frame: Baseline, month 4, month 16, month 22
Percentage change in LDL-C from baseline by ≥50%
Percentage change in LDL-C from baseline by ≥50%
Time frame: Month 4, month 10, month 16, month 22
Percentage change in LDL-C from baseline by ≥30%
Percentage change in LDL-C from baseline by ≥30%
Time frame: Month 4, month 10, month 16, month 22
Proportion of participants achieving LDL-C<55 mg/dL
Proportion of participants achieving LDL-C\<55 mg/dL
Time frame: Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22
Proportion of participants achieving LDL-C<70 mg/dL
Proportion of participants achieving LDL-C\<70 mg/dL
Time frame: Month 4, month 10, month 16 and month 22
Time-averaged percentage change in LDL-C from baseline
Time-averaged percentage change in LDL-C from baseline
Time frame: Baseline, month 4, month 10, month 16 and month 22
Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months
Proportion of participants achieving ≥50% reduction in LDL C at month 10 and maintaining this at 16, 22 and 24 months
Time frame: Month 10, month 16, month 22 and month 24
Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months
Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months
Time frame: Baseline, month 10, month 24
Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months
Proportion of participants achieving \<55 mg/dL and \<70 mg/dL in LDL-C at 10 months and maintaining until 24 months
Time frame: Month 10 and month 24
Inclisiran cohort : Percentage of days covered by inclisiran
Inclisiran cohort : Percentage of days covered by inclisiran
Time frame: 12 months and 24 months
Inclisiran cohort : Mean PDC
Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected
Time frame: 12 months and 24 months
Inclisiran cohort : Proportion of participants with a PDC ≥ 80%
Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)
Time frame: 12 months and 24 months
Proportion of participants remaining on initial baseline therapy
Proportion of patients remaining on initial baseline therapy in the inclisiran cohort
Time frame: Baseline, month 12 and month 24
Time to discontinuation of any newly initiated therapies
Time to discontinuation of any newly initiated therapies
Time frame: Month 12 and month 24
Time to discontinuation of any newly initiated therapies by specific LLT
Time to discontinuation of any newly initiated therapies by specific LLT
Time frame: Month 12 and month 24
Change from baseline in scores from the TSQM (modified) instrument
The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. TSQM V1.4 has a score range of 0 to 100 with with higher scores indicating higher patient satisfaction with medication.
Time frame: Baseline, month 12 and month 24
Descriptive adherence data based on Adherence AAQ
Adherence Assessment Questionnaires (AAQ) measures the degree of identified non-adherence to LLT therapy. AAQ has a score range from 0 (not adherent at all) to 100 (absolute adherent).
Time frame: Month 12 and month 24
Descriptive adherence data based on ABQ
Adherence Barriers Questionnaire (ABQ) is an instrument for identifying specific barriers to medication-related adherence. ABQ is a descriptive analysis. The number and proportion of patients affected by each barrier will be reported for inclisiran participants.
Time frame: Month 12 and month 24
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals