NCT04666298

Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), Day 1 study drug administration, two additional injections on Day 90 and Day 270, and the follow-up period to Day 360. The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit. After the primary analysis, double-blind treatment period were maintained to Day 360, although specific sponsor members (except for blinded monitors) were unblinded for the regulatory submission in Japan.

Conditions

• Hypercholesterolemia
• Heterozygous Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Inclisiran sodium	Subcutaneously injected on Day 1, 90 and 270.
DRUG	Placebo	Subcutaneously injected on Day 1, 90, and 270.

Timeline

• Start date: 2021-01-29
• Primary completion: 2022-04-18
• Completion: 2022-10-19
• First posted: 2020-12-14
• Last updated: 2024-06-20
• Results posted: 2023-05-10

Locations

42 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study