Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on… (NCT05192941) | Clinical Trial Compass
CompletedPhase 4
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia
Bulgaria1,770 participantsStarted 2022-04-08
Plain-language summary
Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Written informed consent must be obtained before any assessment is performed.
✓. Male or female participants ≥18 years of age.
✓. Participants categorized as very high or high CV risk, as defined below:
✓. LDL-C levels:
✓. in participants with very high cardiovascular risk: serum LDL-C ≥55 mg/dL
✓. in participants with high cardiovascular risk: serum LDL-C ≥70 mg/dL
✓. Participant on a stable dose of a statin for ≥ 30 days.
✓. Up to approximately 20% of total participants can be on a stable dose (for ≥ 30 days prior to screening) of another LLT on top of statin such as a cholesterol absorbing inhibitor or a bile acid sequestrant, or alternatively, an adenosine triphosphate citrate lyase (ACL) inhibitor, as indicated.
Exclusion criteria
✕. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 2 years at screening or baseline visit.
✕. Participants on more than one other lipid-lowering drug on top of statin at screening visit.
✕. Pre-existing diagnosis of homozygous familial hypercholesterolemia at screening or baseline visit.
✕. Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome at screening or baseline visit.
What they're measuring
1
Number of Participants Achieving Individual LDL-C Target (<55 mg/dL or <70 mg/dL)
✕. Previous (within 90 days of screening), current or planned treatment with a monoclonal antibody (mAb) directed towards PCSK9 (e.g. evolocumab, alirocumab) at screening or baseline visit.
✕. Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within 2 years prior to screening or baseline visit.
✕. Previous, current or planned treatment with LDL-apheresis at screening or baseline visit.
✕. Participants with known intolerance to rosuvastatin at screening or baseline visit.