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

Plain-language summary

This study evaluated the efficacy and safety of Inclisiran as a stand-alone treatment (monotherapy) in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated LDL cholesterol, with placebo used for comparison. It included eligible adults with a fasting LDL-C of 130 mg/dL or higher. It was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Novartis Pharmaceuticals

Intervention

Inclisiran, Matching Placebo for Inclisiran

Start date

7/11/2023

Estimated completion

10/24/2024

Countries

China

Related genes

Locations

• Fuzhou, China
• Guangzhou, China
• Guangzhou, China
• Zhongshan, China
• Wuhan, China
• Changsha, China
• Changsha, China
• Hohhot, China
• Changzhou, China
• Xuzhou, China
• Nanchang, China
• Jinzhou, China
• Linyi, China
• Taiyuan, China
• Xian, China
• Chengdu, China
• Tianjin, China
• Hangzhou, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Jinan, China
• Shanghai, China
• Shanghai, China
• Shanghai, China
• Tianjin, China
• Tianjin, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.