At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,770 enrolled
Drug / intervention
Inclisiran Sodium +1 moredrug
Likely dose
Placebo 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy, Safety, Tolerability and Quality of Life of Ongoing Individually Optimized Lipid-lowering Therapy With or Without Inclisiran (KJX839) - a Randomized, Placebo-controlled, Double-blind Multicenter Phase IV Study in Participants With Hypercholesterolemia
In Brief
A Phase 4 clinical trial evaluating Inclisiran Sodium and Placebo for Hypercholesterolemia. Completed, enrolled 1,770 participants across 136 sites in 8 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesBulgaria, Czechia, Estonia, France, Germany, Latvia, Poland, Spain
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedJan 2022
Enrollment StartApr 2022
Primary CompletionJun 2024
Study CompletionMar 2025
TodayJul 2026
First PostedJan 14, 2022
Enrollment StartApr 8, 2022
Primary CompletionJun 11, 2024
Study CompletionMar 19, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.5 years ago
Interventions
Inclisiran Sodiumdrug
Subcutaneously injected on Day 1, Day 90, and Day 270
Placebodrug
Placebo to inclisiran 300 mg subcutaneously