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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)

Primary Purpose

Primary Hypercholesterolemia or Mixed Dyslipidemia

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Inclisiran
Matching Placebo for Inclisiran
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia or Mixed Dyslipidemia focused on measuring Inclisiran, LDL-C, monotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inclisiran

Placebo

Arm Description

Inclisiran s.c

Placebo s.c.

Outcomes

Primary Outcome Measures

Percentage change in Low-density Lipoprotein Cholesterol(LDL-C) from baseline
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline at Day 150 compared to placebo

Secondary Outcome Measures

Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline
Absolute change in LDL-C from baseline at Day 150 compared to placebo
Percentage change from baseline in protein convertase subtilisin/kexin type 9 (PCSK9)
Percentage change from baseline at Day 150 in PCSK9 compared to placebo
Absolute change from baseline in protein convertase subtilisin/kexin type 9 (PCSK9)
Absolute change from baseline at Day 150 in PCSK9 compared to placebo
Percentage change from baseline in total cholesterol
Percentage change from baseline at Day 150 in total cholesterol (TC) compared to placebo
Percentage change from baseline in high-density lipoprotein cholesterol (HDL-C)
Percentage change from baseline at Day 150 in HDL-C compared to placebo
Percentage change from baseline in non-HDL-C
Percentage change from baseline at Day 150 in non-HDL-C compared to placebo
Percentage change from baseline in apolipoprotein B (ApoB)
Percentage change from baseline at Day 150 in ApoB compared to placebo
Percentage change from baseline in apolipoprotein A-1 (ApoA-1)
Percentage change from baseline at Day 150 in ApoA-1 compared to placebo
Percentage change from baseline in lipoprotein (a) (Lp(a))
Percentage change from baseline at Day 150 in Lp(a) compared to placebo
Percentage change from baseline in triglycerides
Percentage change from baseline at Day 150 in triglycerides (TG) compared to placebo
Absolute change from baseline in total cholesterol
Absolute change from baseline at Day 150 in total cholesterol (TC) compared to placebo
Absolute change from baseline in high-density lipoprotein cholesterol (HDL-C)
Absolute change from baseline at Day 150 in HDL-C compared to placebo
Absolute change from baseline in non-HDL-C
Absolute change from baseline at Day 150 in non-HDL-C compared to placebo
Absolute change from baseline in apolipoprotein B (ApoB)
Absolute change from baseline at Day 150 in ApoB compared to placebo
Absolute change from baseline in apolipoprotein A-1 (ApoA-1)
Absolute change from baseline at Day 150 in ApoA-1 compared to placebo
Absolute change from baseline in lipoprotein (a) (Lp(a))
Absolute change from baseline at Day 150 in Lp(a) compared to placebo
Absolute change from baseline in triglycerides
Absolute change from baseline at Day 150 in triglycerides (TG) compared to placebo
Percentage change in LDL-C from baseline for inclisiran group
Percentage change in lipoprotein cholesterol (LDL-C) from baseline at Day 330 for inclisiran group
Absolute change in LDL-C from baseline for inclisiran group
Absolute change in lipoprotein cholesterol (LDL-C) from baseline at Day 330 for inclisiran group
Number of participants with Adverse Events (AEs) during core part
Adverse Events (AEs), abnormal vital signs and safety laboratory values during core part
Number of participants with Adverse Events (AEs) during extension part
Adverse Events (AEs), and abnormal vital signs and safety laboratory values during extension part

Full Information

First Posted
May 24, 2023
Last Updated
October 6, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05888103
Brief Title
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
Acronym
V-Mono China
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
February 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This study is designed as a randomized, double-blind, multi-center phase 3 trial, with a placebo-controlled period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300mg s.c. in participants aged 18~75 years with low or moderate ASCVD risk and fasting LDL-C value of ≥ 130 mg/dL but < 190 mg/dL who are not on any lipid lowering therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia or Mixed Dyslipidemia
Keywords
Inclisiran, LDL-C, monotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, randomized, double-blind, placebo-controlled, parallel groups
Masking
ParticipantCare ProviderInvestigator
Masking Description
Sponsor Personnel participating in the study conduct will also be blinded.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inclisiran
Arm Type
Experimental
Arm Description
Inclisiran s.c
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo s.c.
Intervention Type
Drug
Intervention Name(s)
Inclisiran
Other Intervention Name(s)
KJX839
Intervention Description
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran*) in 1.5 mL
Intervention Type
Drug
Intervention Name(s)
Matching Placebo for Inclisiran
Other Intervention Name(s)
Placebo s.c.
Intervention Description
Matching s.c. placebo in 1.5 mL
Primary Outcome Measure Information:
Title
Percentage change in Low-density Lipoprotein Cholesterol(LDL-C) from baseline
Description
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline at Day 150 compared to placebo
Time Frame
Baseline, Day 150
Secondary Outcome Measure Information:
Title
Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline
Description
Absolute change in LDL-C from baseline at Day 150 compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change from baseline in protein convertase subtilisin/kexin type 9 (PCSK9)
Description
Percentage change from baseline at Day 150 in PCSK9 compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in protein convertase subtilisin/kexin type 9 (PCSK9)
Description
Absolute change from baseline at Day 150 in PCSK9 compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change from baseline in total cholesterol
Description
Percentage change from baseline at Day 150 in total cholesterol (TC) compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change from baseline in high-density lipoprotein cholesterol (HDL-C)
Description
Percentage change from baseline at Day 150 in HDL-C compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change from baseline in non-HDL-C
Description
Percentage change from baseline at Day 150 in non-HDL-C compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change from baseline in apolipoprotein B (ApoB)
Description
Percentage change from baseline at Day 150 in ApoB compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change from baseline in apolipoprotein A-1 (ApoA-1)
Description
Percentage change from baseline at Day 150 in ApoA-1 compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change from baseline in lipoprotein (a) (Lp(a))
Description
Percentage change from baseline at Day 150 in Lp(a) compared to placebo
Time Frame
Baseline, day 150
Title
Percentage change from baseline in triglycerides
Description
Percentage change from baseline at Day 150 in triglycerides (TG) compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in total cholesterol
Description
Absolute change from baseline at Day 150 in total cholesterol (TC) compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in high-density lipoprotein cholesterol (HDL-C)
Description
Absolute change from baseline at Day 150 in HDL-C compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in non-HDL-C
Description
Absolute change from baseline at Day 150 in non-HDL-C compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in apolipoprotein B (ApoB)
Description
Absolute change from baseline at Day 150 in ApoB compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in apolipoprotein A-1 (ApoA-1)
Description
Absolute change from baseline at Day 150 in ApoA-1 compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in lipoprotein (a) (Lp(a))
Description
Absolute change from baseline at Day 150 in Lp(a) compared to placebo
Time Frame
Baseline, Day 150
Title
Absolute change from baseline in triglycerides
Description
Absolute change from baseline at Day 150 in triglycerides (TG) compared to placebo
Time Frame
Baseline, Day 150
Title
Percentage change in LDL-C from baseline for inclisiran group
Description
Percentage change in lipoprotein cholesterol (LDL-C) from baseline at Day 330 for inclisiran group
Time Frame
Baseline, Day 330
Title
Absolute change in LDL-C from baseline for inclisiran group
Description
Absolute change in lipoprotein cholesterol (LDL-C) from baseline at Day 330 for inclisiran group
Time Frame
Baseline, Day 330
Title
Number of participants with Adverse Events (AEs) during core part
Description
Adverse Events (AEs), abnormal vital signs and safety laboratory values during core part
Time Frame
Up to 180 days
Title
Number of participants with Adverse Events (AEs) during extension part
Description
Adverse Events (AEs), and abnormal vital signs and safety laboratory values during extension part
Time Frame
From day 181, up to day 360

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Guangzhou City
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410003
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221003
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030002
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
101200
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fuzhou
ZIP/Postal Code
350004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

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

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