Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
V-Mono China
A 6 Month Randomized, Double-blind, Placebo-controlled Study Followed by a 6 Month Open- Label Extension to Assess the Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol
1 other identifier
interventional
207
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2023
Shorter than P25 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2024
CompletedResults Posted
Study results publicly available
April 20, 2025
CompletedJanuary 13, 2026
December 1, 2025
9 months
May 24, 2023
April 1, 2025
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Baseline, Day 150
Secondary Outcomes (22)
Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Baseline, Day 150
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
Baseline, Day 150
Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
Baseline, Day 150
Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Baseline, Day 150
Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Baseline, Day 150
- +17 more secondary outcomes
Study Arms (2)
Inclisiran - Inclisiran
EXPERIMENTALInclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Day 1, Day 90, and Day 270, and placebo on Day 180
Placebo- Inclisiran
PLACEBO COMPARATORPlacebo on Day 1 and Day 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c on Day 180 and 270
Interventions
Matching s.c. placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Novartis Investigative Site
Fuzhou, Fujian, 350025, China
Novartis Investigative Site
Guangzhou, Guangdong, 510000, China
Novartis Investigative Site
Guangzhou, Guangdong, 510515, China
Novartis Investigative Site
Zhongshan, Guangdong, 528403, China
Novartis Investigative Site
Wuhan, Hubei, 430022, China
Novartis Investigative Site
Changsha, Hunan, 410003, China
Novartis Investigative Site
Changsha, Hunan, 410011, China
Novartis Investigative Site
Hohhot, Inner Mongolia, 010017, China
Novartis Investigative Site
Changzhou, Jiangsu, 213004, China
Novartis Investigative Site
Xuzhou, Jiangsu, 221003, China
Novartis Investigative Site
Nanchang, Jiangxi, 330009, China
Novartis Investigative Site
Jinzhou, Liaoning, 121001, China
Novartis Investigative Site
Linyi, Shandong, 276000, China
Novartis Investigative Site
Taiyuan, Shanxi, 030002, China
Novartis Investigative Site
Xian, Shanxi, 710061, China
Novartis Investigative Site
Chengdu, Sichuan, 610041, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310006, China
Novartis Investigative Site
Beijing, 100029, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Beijing, 100730, China
Novartis Investigative Site
Beijing, 101200, China
Novartis Investigative Site
Jinan, 250012, China
Novartis Investigative Site
Shanghai, 200025, China
Novartis Investigative Site
Shanghai, 200080, China
Novartis Investigative Site
Shanghai, 200120, China
Novartis Investigative Site
Tianjin, 300052, China
Novartis Investigative Site
Tianjin, 300140, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor Personnel participating in the study conduct were also blinded during the during core part of the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
June 5, 2023
Study Start
July 11, 2023
Primary Completion
April 2, 2024
Study Completion
October 24, 2024
Last Updated
January 13, 2026
Results First Posted
April 20, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient level data and supporting clinical documents from eligible studies. these requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.