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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05888103
• Collaborator: (none)
• Enrollment: 200
• Arms: 2
• Anticipated Duration (Months): 17.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia or Mixed Dyslipidemia	Drug: Inclisiran; Drug: Matching Placebo for Inclisiran	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Multi-center, randomized, double-blind, placebo-controlled, parallel groupsMulti-center, randomized, double-blind, placebo-controlled, parallel groups
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Sponsor Personnel participating in the study conduct will also be blinded.
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 25, 2023
• Anticipated Primary Completion Date: Aug 20, 2024
• Anticipated Study Completion Date: Feb 16, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inclisiran Inclisiran s.c	Drug: Inclisiran; Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran*) in 1.5 mL; Other Names: KJX839
Placebo Comparator: Placebo Placebo s.c.	Drug: Matching Placebo for Inclisiran; Matching s.c. placebo in 1.5 mL; Other Names: Placebo s.c.

Outcome Measures

Primary Outcome Measures

1. Percentage change in Low-density Lipoprotein Cholesterol(LDL-C) from baseline [Baseline, Day 150]

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

Secondary Outcome Measures

1. Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline [Baseline, Day 150]

   Absolute change in LDL-C from baseline at Day 150 compared to placebo

2. Percentage change from baseline in protein convertase subtilisin/kexin type 9 (PCSK9) [Baseline, Day 150]

   Percentage change from baseline at Day 150 in PCSK9 compared to placebo

3. Absolute change from baseline in protein convertase subtilisin/kexin type 9 (PCSK9) [Baseline, Day 150]

   Absolute change from baseline at Day 150 in PCSK9 compared to placebo

4. Percentage change from baseline in total cholesterol [Baseline, Day 150]

   Percentage change from baseline at Day 150 in total cholesterol (TC) compared to placebo

5. Percentage change from baseline in high-density lipoprotein cholesterol (HDL-C) [Baseline, Day 150]

   Percentage change from baseline at Day 150 in HDL-C compared to placebo

6. Percentage change from baseline in non-HDL-C [Baseline, Day 150]

   Percentage change from baseline at Day 150 in non-HDL-C compared to placebo

7. Percentage change from baseline in apolipoprotein B (ApoB) [Baseline, Day 150]

   Percentage change from baseline at Day 150 in ApoB compared to placebo

8. Percentage change from baseline in apolipoprotein A-1 (ApoA-1) [Baseline, Day 150]

   Percentage change from baseline at Day 150 in ApoA-1 compared to placebo

9. Percentage change from baseline in lipoprotein (a) (Lp(a)) [Baseline, day 150]

   Percentage change from baseline at Day 150 in Lp(a) compared to placebo

10. Percentage change from baseline in triglycerides [Baseline, Day 150]

    Percentage change from baseline at Day 150 in triglycerides (TG) compared to placebo

11. Absolute change from baseline in total cholesterol [Baseline, Day 150]

    Absolute change from baseline at Day 150 in total cholesterol (TC) compared to placebo

12. Absolute change from baseline in high-density lipoprotein cholesterol (HDL-C) [Baseline, Day 150]

    Absolute change from baseline at Day 150 in HDL-C compared to placebo

13. Absolute change from baseline in non-HDL-C [Baseline, Day 150]

    Absolute change from baseline at Day 150 in non-HDL-C compared to placebo

14. Absolute change from baseline in apolipoprotein B (ApoB) [Baseline, Day 150]

    Absolute change from baseline at Day 150 in ApoB compared to placebo

15. Absolute change from baseline in apolipoprotein A-1 (ApoA-1) [Baseline, Day 150]

    Absolute change from baseline at Day 150 in ApoA-1 compared to placebo

16. Absolute change from baseline in lipoprotein (a) (Lp(a)) [Baseline, Day 150]

    Absolute change from baseline at Day 150 in Lp(a) compared to placebo

17. Absolute change from baseline in triglycerides [Baseline, Day 150]

    Absolute change from baseline at Day 150 in triglycerides (TG) compared to placebo

18. Percentage change in LDL-C from baseline for inclisiran group [Baseline, Day 330]

    Percentage change in lipoprotein cholesterol (LDL-C) from baseline at Day 330 for inclisiran group

19. Absolute change in LDL-C from baseline for inclisiran group [Baseline, Day 330]

    Absolute change in lipoprotein cholesterol (LDL-C) from baseline at Day 330 for inclisiran group

20. Number of participants with Adverse Events (AEs) during core part [Up to 180 days]

    Adverse Events (AEs), abnormal vital signs and safety laboratory values during core part

21. Number of participants with Adverse Events (AEs) during extension part [From day 181, up to day 360]

    Adverse Events (AEs), and abnormal vital signs and safety laboratory values during extension part

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05888103
• Other Study ID Numbers: CKJX839D12305
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Inclisiran, LDL-C, monotherapy
• Additional relevant MeSH terms: Hypercholesterolemia; Dyslipidemias

Study Results

No Results Posted as of Jun 5, 2023