Trial results for Inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) were posted on ClinicalTrials.gov on 2025-04-20. The study demonstrated that Inclisiran significantly reduced LDL-C by -45.87% from baseline at Day 150, compared to a 1.62% increase in the placebo group.

Background

This study investigated Inclisiran as a monotherapy for Chinese adults diagnosed with Primary Hypercholesterolemia or Mixed Dyslipidemia. The trial specifically focused on individuals with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not receiving any other lipid-lowering therapy at baseline.

Trial design

The study (NCT05888103) was a Phase 3 trial that enrolled 207 participants. It evaluated the efficacy and safety of Inclisiran as a monotherapy in Chinese adults with Primary Hypercholesterolemia or Mixed Dyslipidemia. Participants were randomized to receive either Inclisiran or a matching placebo for Inclisiran. The primary objective was to evaluate the efficacy and safety of Inclisiran as a monotherapy in this specific patient population.

Key results

The trial results demonstrated significant reductions in lipid parameters for the Inclisiran group compared to placebo at Day 150. For the percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline:

An ANCOVA analysis for the difference between groups indicated a least squares mean difference of -47.5% (95.0% Confidence Interval: -52.35 to -42.65) with a p-value of 0.0001.

For the absolute change in LDL-C from baseline:

The least squares mean difference between groups was -69.73 mg/dL (95.0% Confidence Interval: -76.6 to -62.86) with a p-value of 0.0001.

Regarding the percentage change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) from baseline:

The least squares mean difference between groups was -77.83% (95.0% Confidence Interval: -85.86 to -69.8) with a p-value of 0.0001.

For the absolute change in PCSK9 from baseline:

The least squares mean difference between groups was -226.61 ng/mL (95.0% Confidence Interval: -244.77 to -208.45) with a p-value of 0.0001.

For the percentage change in Total Cholesterol from baseline:

The least squares mean difference between groups was -31.49% (95.0% Confidence Interval: -34.91 to -28.07) with a p-value of 0.0001.

For the absolute change in Total Cholesterol from baseline:

The least squares mean difference between groups was -71.46 mg/dL (95.0% Confidence Interval: -79.24 to -63.69) with a p-value of 0.0001.

What this means

The results from this Phase 3 trial indicate that Inclisiran monotherapy significantly reduced LDL-C, PCSK9, and total cholesterol levels in Chinese adults with low or moderate ASCVD risk and elevated LDL-C. The substantial reductions observed across multiple lipid parameters, along with the highly statistically significant p-values, suggest that Inclisiran could be an effective treatment option for managing hypercholesterolemia and mixed dyslipidemia in this specific patient population, particularly as a monotherapy for those not currently on other lipid-lowering treatments.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05888103, titled "Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol," were posted on 2025-04-20 on clinicaltrials.gov.