Clinical trial NCT05763875: Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: inclisiran
ezetimibe
LDL-C
monotherapy
primary hypercholesterolemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, randomized, double-blind, placebo-controlled, parallel groups
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo
timeFrame: Baseline, Day 150
measure: Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe
timeFrame: Baseline, Day 150
Secondary outcomes:
measure: Absolute change in LDL-C from Baseline to Day 150
timeFrame: Baseline, Day 150
measure: Percentage change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline to Day 150
timeFrame: Baseline, Day 150
measure: Percentage change in non-High-Density Lipoprotein Cholesterol (non-HDL-C) from Baseline to Day 150
timeFrame: Baseline, Day 150
measure: Percentage change in Total Cholesterol (TC)/HDL-C ratio from Baseline to Day 150
timeFrame: Baseline, Day 150
measure: Percentage change in Apolipoprotein B (Apo B) from Baseline to Day 150
timeFrame: Baseline, Day 150
measure: Percentage change in Apo B/Apo A-1 ratio from Baseline to Day 150
timeFrame: Baseline, Day 150
measure: Percentage change in Lipoprotein (a) [Lp(a)] from Baseline to Day 150
timeFrame: Baseline, Day 150
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Dothan
country: United States
facility: Novartis Investigative Site
state: Alabama
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Maitland
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinical LLC
state: Florida
city: Miami
country: United States
facility: Alma Clinical Research Inc
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research
state: Florida
city: Plant City
country: United States
facility: Fam Medical Specialists Of Fl Plc
state: Florida
city: Zephyrhills
country: United States
facility: Novartis Investigative Site
state: Florida
city: Morton
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Bossier City
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Shreveport
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Zachary
country: United States
facility: Southern Clin Research Clinic .
state: Louisiana
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research .
state: North Carolina
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Huber Heights
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Edmond
country: United States
facility: Conrad Clinical Research Research
state: Oklahoma
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Sugar Land
country: United States
facility: Novartis Investigative Site
state: Texas
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: West Bend
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Floridablanca
country: Colombia
facility: Novartis Investigative Site
state: Santander
city: Manizales
country: Colombia
facility: Novartis Investigative Site
city: San Gil
country: Colombia
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Gladbeck
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Jerichow
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Papenburg
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Merida
country: Mexico
facility: Novartis Investigative Site
state: Yucatan
city: Culiacan Sinaloa
country: Mexico
facility: Novartis Investigative Site
city: Queretaro
country: Mexico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: