Phase 3
N=207
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
Primary Hypercholesterolemia or Mixed Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT05888103 ↗Enrolled (actual)
207
Serious AEs
2.7%
Results posted
Apr 2025
Primary outcome: Primary: Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part — -45.87; 1.62 % change in LDL-C — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inclisiran (Drug); Matching Placebo for Inclisiran (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-45.87; 1.62 | <0.0001 sig |
| SECONDARY Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-69.05; 0.68 | <0.0001 sig |
| SECONDARY Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part |
-71.95; 5.88 | <0.0001 sig |
| SECONDARY Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part |
-217.14; 9.47 | <0.0001 sig |
| SECONDARY Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-29.88; 1.61 | <0.0001 sig |
| SECONDARY Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-68.82; 2.64 | <0.0001 sig |
| SECONDARY Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
12.24; 9.30 | 0.3743 |
| SECONDARY Absolute Change in HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
4.66; 3.60 | 0.4228 |
| SECONDARY Percentage Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-40.71; -0.14 | <0.0001 sig |
| SECONDARY Absolute Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-73.48; -1.14 | <0.0001 sig |
| SECONDARY Percentage Change in Apolipoprotein B (ApoB) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-36.63; 0.21 | <0.0001 sig |
| SECONDARY Absolute Change in ApoB (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-42.64; -0.76 | <0.0001 sig |
| SECONDARY Percentage Change in Apolipoprotein A-1 (ApoA-1) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
5.11; 3.06 | 0.3011 |
| SECONDARY Absolute Change in ApoA-1 (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
6.44; 3.31 | 0.2403 |
| SECONDARY Percentage Change in Lipoprotein (a) (Lp(a)) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part |
-23.84; 6.43 | <0.0001 sig |
| SECONDARY Absolute Change in Log-transformed Lp(a) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part |
0.68; 1.01 | <0.0001 sig |
| SECONDARY Percentage Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
3.49; 0.48 | 0.5877 |
| SECONDARY Absolute Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part |
-15.32; -7.36 | 0.5019 |
| SECONDARY Percentage Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part |
-45.45 | — |
| SECONDARY Absolute Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part |
-67.55 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) During Core Part |
73; 70; 14; 4; 5; 3 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) During Extension Part |
52; 47; 9; 15; 1; 2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part) |
85; 81; 18; 18; 6; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Fasting LDL-C of ≥ 130 mg/dL but < 190 mg/dL
- Triglycerides ≤ 400 mg/dL
- Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline
Exclusion Criteria
- Use of any LLT within 90 days prior to screening visit
- History of ASCVD
- Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
- Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05888103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.