CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 312 enrolled
Drug / intervention
Inclisiran sodium +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.

Search/NCT04666298
NCT04666298Phase 2Completed
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A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Effect of Different Doses of Inclisiran Given as Subcutaneous Injections in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

Novartis Pharmaceuticals·interventional·Posted Dec 14, 2020·Updated Jun 20, 2024

In Brief

A Phase 2 clinical trial evaluating Inclisiran sodium and Placebo for Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia. Completed, enrolled 312 participants across 42 sites.

Detailed Summary

This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Heterozygous Familial Hypercholesterolemia
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 14, 2020
Enrollment StartJan 29, 2021
Primary CompletionApr 18, 2022
Study CompletionOct 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.5 years ago

Interventions

Inclisiran sodiumdrug

Subcutaneously injected on Day 1, 90 and 270.

Placebodrug

Subcutaneously injected on Day 1, 90, and 270.