At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 207 enrolled
Drug / intervention
Inclisiran +1 moredrug
Likely dose
Not stated in 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.
A 6 Month Randomized, Double-blind, Placebo-controlled Study Followed by a 6 Month Open- Label Extension to Assess the Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol
In Brief
A Phase 3 clinical trial evaluating Inclisiran and Matching Placebo for Inclisiran for Primary Hypercholesterolemia or Mixed Dyslipidemia. Completed, enrolled 207 participants across 28 sites.
Detailed Summary
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedJun 2023
Enrollment StartJul 2023
Primary CompletionApr 2024
Study CompletionOct 2024
TodayJul 2026
First PostedJun 5, 2023
Enrollment StartJul 11, 2023
Primary CompletionApr 2, 2024
Study CompletionOct 24, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.1 years ago
Interventions
Inclisirandrug
Inclisiran s.c
Matching Placebo for Inclisirandrug
Matching s.c. placebo