Trial record 1 of 1 for:
CKJX839D12304
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. (V-Mono)
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| ClinicalTrials.gov Identifier: NCT05763875 |
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Recruitment Status :
Recruiting
First Posted : March 10, 2023
Last Update Posted : April 10, 2024
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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%.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: Inclisiran Drug: Ezetimibe Drug: Matching Placebo for Inclisiran Drug: Matching Placebo for Ezetimibe | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Multi-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 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) |
| Actual Study Start Date : | March 15, 2023 |
| Estimated Primary Completion Date : | June 21, 2024 |
| Estimated Study Completion Date : | June 21, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Cholesterol
Cholesterol Levels: What You Need to Know
Cholesterol Medicines
Drug Information
available for:
Ezetimibe
| Arm | Intervention/treatment |
|---|---|
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Experimental: Inclisiran
Inclisiran s.c and Placebo p.o
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Drug: Inclisiran
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
Other Name: KJX839 Drug: Matching Placebo for Ezetimibe 0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Other Name: Placebo p.o. |
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Active Comparator: Ezetimibe
Placebo s.c. and Ezetimibe p.o.
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Drug: Ezetimibe
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
Other Name: Sandoz ezetimibe Drug: Matching Placebo for Inclisiran 0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Other Name: Placebo s.c. |
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Placebo Comparator: Placebo
Placebo s.c. and Placebo p.o.
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Drug: Matching Placebo for Inclisiran
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Other Name: Placebo s.c. Drug: Matching Placebo for Ezetimibe 0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Other Name: Placebo p.o. |
Primary Outcome Measures :
- Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo [ Time Frame: Baseline, Day 150 ]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 [ Time Frame: Baseline, Day 150 ]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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, Day 150 ]Percentage change in Lp(a) from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05763875
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals | +41613241111 |
Locations
Show 48 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT05763875 |
| Other Study ID Numbers: |
CKJX839D12304 |
| First Posted: | March 10, 2023 Key Record Dates |
| Last Update Posted: | April 10, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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inclisiran ezetimibe LDL-C monotherapy primary hypercholesterolemia |
Additional relevant MeSH terms:
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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |