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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05763875
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. This study was 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%.

Key Dates

Start date
Mar 15, 2023
Status verified
Oct 2025
Primary completion
Jun 20, 2024
Completion
Jun 20, 2024

Study Design

Enrollment
350 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inclisiran
    Inclisiran s.c and Placebo p.o
  • Active Comparator: Ezetimibe
    Placebo s.c. and Ezetimibe p.o.
  • Placebo Comparator: Placebo
    Placebo s.c. and Placebo p.o.

Primary Outcome Measure

Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150 [ Time Frame: Baseline, Day 150 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Parkway Medical CenterBirminghamAlabama35215-
SEC Clinical ResearchDothanAlabama36305-
Hillcrest Medical ResearchDeLandFlorida32720-
ClinCloudMaitlandFlorida32751-
Alma Clinical Research IncMiamiFlorida33165-
Inpatient Research Clinical LLCMiami LakesFlorida33014-
Harmony Clinical ResearchNorth Miami BeachFlorida33162-
Fam Medical Specialists Of Fl PlcPlant CityFlorida33563-
Cozy Research LLCZephyrhillsFlorida33541-
Koch Family MedicineMortonIllinois61550-
Grace Research LLCBossier CityLouisiana71111-
Grace Research LlcShreveportLouisiana71101-
Southern Clin Research ClinicZacharyLouisiana70791-
Prime Global Research IncThe BronxNew York10456-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
Lillestol Research LLCFargoNorth Dakota58103-
WellNow Urgent Care and ResearchHuber HeightsOhio45424-
Conrad Clinical ResearchEdmondOklahoma73013-
Compass Point ResearchNashvilleTennessee37203-
Mt Olympus Medical ResearchSugar LandTexas77479-
Dominion Medical AssociatesRichmondVirginia23219-
Spaulding Clinical ResearchWest BendWisconsin53095-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
Parkway Medical Center· Birmingham, ALSEC Clinical Research· Dothan, ALHillcrest Medical Research· DeLand, FLClinCloud· Maitland, FLAlma Clinical Research Inc· Miami, FLInpatient Research Clinical LLC· Miami Lakes, FL

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