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Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. (V-Mono)

Primary Purpose

Hypercholesterolemia

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

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring inclisiran, ezetimibe, LDL-C, monotherapy, primary hypercholesterolemia

Eligibility Criteria

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

Inclusion Criteria to be met at screening: informed consent must be signed prior to participation in study fasting LDL-C of >= 100mg/dL but < 190mg/dL fasting triglycerides <= 400 mg/dL 10-year ASCVD risk score < 7.5% not on any lipid-lowering therapy within 90 days Key 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 (TSH above upper limit of normal) 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 Site
  • 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 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Inclisiran

Ezetimibe

Placebo

Arm Description

Inclisiran s.c and Placebo p.o

Placebo s.c. and Ezetimibe p.o.

Placebo s.c. and Placebo p.o.

Outcomes

Primary Outcome Measures

Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo
Percentage change in LDL-C from Baseline (Day 1) to Day 150 comparing Inclisiran arm versus Placebo arm
Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe
Percentage change in LDL-C from Baseline (Day 1) to Day 150 comparing Inclisiran arm versus Ezetimibe arm.

Secondary Outcome Measures

Absolute change in LDL-C from Baseline to Day 150
Absolute change in LDL-C from Baseline (Day 1) to Day 150 compared to ezetimibe and placebo
Percentage change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline to Day 150
Percentage change in PCSK9 from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Percentage change in non-High-Density Lipoprotein Cholesterol (non-HDL-C) from Baseline to Day 150
Percentage change in non-HDL-C from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Percentage change in Total Cholesterol (TC)/HDL-C ratio from Baseline to Day 150
Percentage change in total cholesterol (TC)/HDL-C ratio from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Percentage change in Apolipoprotein B (Apo B) from Baseline to Day 150
Percentage change in Apo B from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Percentage change in Apo B/Apo A-1 ratio from Baseline to Day 150
Percentage change in Apo B/Apo A-1 ratio from baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Percentage change in Lipoprotein (a) [Lp(a)] from Baseline to Day 150
Percentage change in Lp(a) from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo

Full Information

First Posted
February 28, 2023
Last Updated
October 2, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05763875
Brief Title
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Acronym
V-Mono
Official Title
A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
August 7, 2024 (Anticipated)
Study Completion Date
August 7, 2024 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
CKJX839D12304 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo or ezetimibe can effectively reduce LDL-C as measured by percentage change from baseline to Day 150. This study is being conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.
Detailed Description
This study is a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 300 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study will evaluate the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo. The study consists of: a screening period of up to 14 days; a double-blind treatment period of 150+/- 5 days during which participants will be randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and a safety follow-up / End of Study visit conducted 30+5 days after the Day 150 visit. The overall study duration is approximately 190 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
inclisiran, ezetimibe, LDL-C, monotherapy, primary hypercholesterolemia

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
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inclisiran
Arm Type
Experimental
Arm Description
Inclisiran s.c and Placebo p.o
Arm Title
Ezetimibe
Arm Type
Active Comparator
Arm Description
Placebo s.c. and Ezetimibe p.o.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo s.c. and Placebo p.o.
Intervention Type
Drug
Intervention Name(s)
Inclisiran
Other Intervention Name(s)
KJX839
Intervention Description
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Sandoz ezetimibe
Intervention Description
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
Intervention Type
Drug
Intervention Name(s)
Matching Placebo for Inclisiran
Other Intervention Name(s)
Placebo s.c.
Intervention Description
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Intervention Type
Drug
Intervention Name(s)
Matching Placebo for Ezetimibe
Other Intervention Name(s)
Placebo p.o.
Intervention Description
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Primary Outcome Measure Information:
Title
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo
Description
Percentage change in LDL-C from Baseline (Day 1) to Day 150 comparing Inclisiran arm versus Placebo arm
Time Frame
Baseline, Day 150
Title
Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe
Description
Percentage change in LDL-C from Baseline (Day 1) to Day 150 comparing Inclisiran arm versus Ezetimibe arm.
Time Frame
Baseline, Day 150
Secondary Outcome Measure Information:
Title
Absolute change in LDL-C from Baseline to Day 150
Description
Absolute change in LDL-C from Baseline (Day 1) to Day 150 compared to ezetimibe and placebo
Time Frame
Baseline, Day 150
Title
Percentage change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline to Day 150
Description
Percentage change in PCSK9 from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Time Frame
Baseline, Day 150
Title
Percentage change in non-High-Density Lipoprotein Cholesterol (non-HDL-C) from Baseline to Day 150
Description
Percentage change in non-HDL-C from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Time Frame
Baseline, Day 150
Title
Percentage change in Total Cholesterol (TC)/HDL-C ratio from Baseline to Day 150
Description
Percentage change in total cholesterol (TC)/HDL-C ratio from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Time Frame
Baseline, Day 150
Title
Percentage change in Apolipoprotein B (Apo B) from Baseline to Day 150
Description
Percentage change in Apo B from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Time Frame
Baseline, Day 150
Title
Percentage change in Apo B/Apo A-1 ratio from Baseline to Day 150
Description
Percentage change in Apo B/Apo A-1 ratio from baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Time Frame
Baseline, Day 150
Title
Percentage change in Lipoprotein (a) [Lp(a)] from Baseline to Day 150
Description
Percentage change in Lp(a) from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Time Frame
Baseline, Day 150

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 to be met at screening: informed consent must be signed prior to participation in study fasting LDL-C of >= 100mg/dL but < 190mg/dL fasting triglycerides <= 400 mg/dL 10-year ASCVD risk score < 7.5% not on any lipid-lowering therapy within 90 days Key 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 (TSH above upper limit of normal) Other protocol-defined inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33541
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30449
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jerichow
ZIP/Postal Code
39319
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Loehne
ZIP/Postal Code
32584
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
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 Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

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