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

Hypercholesterolemia Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05763875
• Other study ID #: CKJX839D12304
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 15, 2023
• Est. completion date: June 21, 2024

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: June 21, 2024
• Est. primary completion date: June 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Inclisiran
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
• Ezetimibe
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
• Matching Placebo for Inclisiran
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
• Matching Placebo for Ezetimibe
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149

Locations

Country	Name	City	State
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Floridablanca	Santander
Colombia	Novartis Investigative Site	Manizales
Colombia	Novartis Investigative Site	San Gil
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Gladbeck
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Jerichow
Germany	Novartis Investigative Site	Loehne
Germany	Novartis Investigative Site	Muenchen	Bavaria
Germany	Novartis Investigative Site	Papenburg
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Pecs
Mexico	Novartis Investigative Site	Culiacan Sinaloa
Mexico	Novartis Investigative Site	Merida	Yucatan
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Mexico	Novartis Investigative Site	Queretaro
United States	Parkway Medical Center	Birmingham	Alabama
United States	Grace Research LLC .	Bossier City	Louisiana
United States	Prime Global Research Inc	Bronx	New York
United States	Hillcrest Medical Research	DeLand	Florida
United States	SEC Clinical Research	Dothan	Alabama
United States	Conrad Clinical Research Research	Edmond	Oklahoma
United States	Lillestol Research LLC .	Fargo	North Dakota
United States	WellNow Urgent Care and Research Research Department	Huber Heights	Ohio
United States	ClinCloud Research	Maitland	Florida
United States	Alma Clinical Research Inc	Miami	Florida
United States	Inpatient Research Clinical LLC	Miami Lakes	Florida
United States	Monroe Biomedical Research .	Monroe	North Carolina
United States	Koch Family Medicine	Morton	Illinois
United States	Compass Point Research Brengle Family Med and Rsch	Nashville	Tennessee
United States	Harmony Clinical Research	North Miami Beach	Florida
United States	Fam Medical Specialists Of Fl Plc	Plant City	Florida
United States	Dominion Medical Associates	Richmond	Virginia
United States	Grace Research Llc .	Shreveport	Louisiana
United States	Mt Olympus Medical Research	Sugar Land	Texas
United States	Spaulding Clinical Research	West Bend	Wisconsin
United States	Southern Clinical Research Clinic .	Zachary	Louisiana
United States	Cozy Research LLC .	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Colombia,  Germany,  Hungary,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, Day 150
Primary	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.	Baseline, Day 150
Secondary	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	Baseline, Day 150
Secondary	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	Baseline, Day 150
Secondary	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	Baseline, Day 150
Secondary	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	Baseline, Day 150
Secondary	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	Baseline, Day 150
Secondary	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	Baseline, Day 150
Secondary	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	Baseline, Day 150