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

• Status: Not yet recruiting
• Trial end date: 2025-02-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is 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 are not on any lipid lowering therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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:

• 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.