Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.

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.

Timeline

Start

2023-07-11

Primary completion

2024-04-02

Completion

2024-10-24

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Inclisiran - Inclisiran: -45.87 (-49.33 to -42.42) % change in LDL-C NCT05888103 ↗

registry analysis (superiority test); Inclisiran - Inclisiran vs Placebo- Inclisiran; p <0.0001; LS Mean Difference -47.50 (95% CI -52.35 to -42.65); ANCOVA NCT05888103 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inclisiran	Small interfering RNA (siRNA)	300 mg	Subcutaneous

Indications