At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 482 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.
Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).
In Brief
A Phase 3 clinical trial evaluating Inclisiran and Placebo for Heterozygous Familial Hypercholesterolemia and Elevated Cholesterol. Completed, enrolled 482 participants across 45 sites in 8 countries.
Detailed Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Denmark, Netherlands, South Africa, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedJan 2018
Primary CompletionAug 2019
Study CompletionSep 2019
TodayJul 2026
First PostedJan 11, 2018
Enrollment StartNov 28, 2017
Primary CompletionAug 27, 2019
Study CompletionSep 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.5 years ago
Interventions
Inclisirandrug
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Placebodrug
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).