A Study Of LY3475766 In Healthy Participants - PlatoHealth (2024)

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  • PlatoHealth
  • Time Stamp: September 2, 20197:00 PM
  • Source Node: 345812

Studies

Study First Submitted Date2019-08-08
Study First Posted Date 2019-08-12
Last Update Posted Date2021-04-28
Start Month YearSeptember 3, 2019
Primary Completion Month YearMarch 31, 2021
Verification Month YearApril 15, 2021
Verification Date2021-04-15
Last Update Posted Date2021-04-28

Facilities

Sequence:200322046Sequence:200322047Sequence:200322048Sequence:200322049
NameWCCT GlobalNameCovance Clinical Research IncNameCovance DallasNameCovance Clinical Research Inc
CityCypressCityDaytona BeachCityDallasCityMadison
StateCaliforniaStateFloridaStateTexasStateWisconsin
Zip90630Zip32117Zip75247Zip53704
CountryUnited StatesCountryUnited StatesCountryUnited StatesCountryUnited States

Conditions

Sequence:52236567
NameDyslipidemias
Downcase Namedyslipidemias

Id Information

Sequence:40206407Sequence:40206408
Id Sourceorg_study_idId Sourcesecondary_id
Id Value17394Id ValueJ1T-MC-GZEA
Id TypeOther Identifier
Id Type DescriptionEli Lilly and Company

Countries

Sequence:42620647
NameUnited States
RemovedFalse

Design Groups

Sequence:55666844Sequence:55666845Sequence:55666846Sequence:55666847
Group TypeExperimentalGroup TypePlacebo ComparatorGroup TypeExperimentalGroup TypePlacebo Comparator
TitleLY3475766 – IVTitlePlacebo – IVTitleLY3475766 – SCTitlePlacebo – SC
DescriptionLY3475766 administered intravenously (IV) to participants with dyslipidemiaDescriptionPlacebo administered IV to participants with dyslipidemiaDescriptionLY3475766 administered subcutaneously (SC) to participants with dyslipidemiaDescriptionPlacebo administered SC to participants with dyslipidemia

Interventions

Sequence:52550209Sequence:52550210Sequence:52550211Sequence:52550212
Intervention TypeDrugIntervention TypeDrugIntervention TypeDrugIntervention TypeDrug
NameLY3475766 – IVNameLY3475766 – SCNamePlacebo – IVNamePlacebo – SC
DescriptionAdministered IVDescriptionAdministered SCDescriptionAdministered IVDescriptionAdministered SC

Design Outcomes

Sequence:177617016Sequence:177617017Sequence:177617018Sequence:177617019Sequence:177617020Sequence:177617021Sequence:177617022
Outcome TypeprimaryOutcome TypesecondaryOutcome TypesecondaryOutcome TypesecondaryOutcome TypesecondaryOutcome TypesecondaryOutcome Typesecondary
MeasureNumber of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationMeasurePharmaco*kinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766MeasurePK: Maximum Observed Drug Concentration (Cmax) of LY3475766MeasurePK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766MeasurePharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG)MeasurePD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)MeasurePD: Percent Change from Baseline in Apolipoprotein B (ApoB)
Time FrameBaseline up to Day 85Time FramePredose up to Day 85Time FramePredose up to Day 85Time FramePredose up to Day 85Time FrameBaseline, Day 85Time FrameBaseline, Day 85Time FrameBaseline, Day 85
DescriptionA summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events moduleDescriptionPK: AUC of LY3475766DescriptionPK: Cmax of LY3475766DescriptionPK: Tmax of LY3475766DescriptionPD: Percent Change from Baseline in TGDescriptionPD: Percent Change from Baseline in LDL-CDescriptionPD: Percent Change from Baseline in ApoB

Browse Conditions

Sequence:193735901Sequence:193735902Sequence:193735903
Mesh TermDyslipidemiasMesh TermLipid Metabolism DisordersMesh TermMetabolic Diseases
Downcase Mesh TermdyslipidemiasDowncase Mesh Termlipid metabolism disordersDowncase Mesh Termmetabolic diseases
Mesh Typemesh-listMesh Typemesh-ancestorMesh Typemesh-ancestor

Sponsors

Sequence:48380696
Agency ClassINDUSTRY
Lead Or Collaboratorlead
NameEli Lilly and Company

Overall Officials

Sequence:29321107
RoleStudy Director
NameCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST)
AffiliationEli Lilly and Company

Design Group Interventions

Sequence:68237775Sequence:68237776Sequence:68237777Sequence:68237778
Design Group Id55666844Design Group Id55666846Design Group Id55666845Design Group Id55666847
Intervention Id52550209Intervention Id52550210Intervention Id52550211Intervention Id52550212

Eligibilities

Sequence:30803632
GenderAll
Minimum Age18 Years
Maximum Age65 Years
Healthy VolunteersAccepts Healthy Volunteers
CriteriaInclusion Criteria:

Are overtly healthy males or females, apart from dyslipidemia
Male participants must agree to adhere to contraception restrictions
Female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are postmenopausal
Have a body mass index (BMI) >18.5 and <40 kilograms per meter squared (kg/m²)
Have clinical laboratory test results within normal reference range, or acceptable deviations per investigator discretion
Have a fasting triglyceride (TG) level that is 135 to 499 milligrams per deciliter (mg/dL), inclusive, at both screening and Day -1
Have a fasting low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL, inclusive, at screening and Day -1
Have had a stable body weight for the 3 months prior to randomization (<5% body weight change)
Have not modified diet or adopted any nutritional lifestyle modification within 3 months prior to randomization

Exclusion Criteria:

Are taking or have started taking Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 3 months prior to randomization; or statins, fibrates, or niacin ≤1000 mg/day within 8 weeks prior to randomization; or niacin >1000 milligrams per day (mg/day) within 16 weeks prior to randomization; or any other lipid-lowering agents within 1 month prior to randomization
Are taking or have started taking a beta-blocker, antiarrhythmic, non-dihydropyridine calcium channel blocker, ivabradine, or any other heart rate lowering agent within 1 month or 5 half-lives prior to randomization, whichever is longer
Have a diagnosis of diabetes mellitus (type 1 diabetes mellitus or type 2 diabetes mellitus) or have 1 of the following at screening: fasting plasma glucose concentration ≥126 mg/dL (7.0 millimoles per liter [mmol/L]) OR a glycated hemoglobin level ≥6.5% (48 millimoles per mole [mmol/mol])
Have previously completed or withdrawn from this study or any other study investigating LY3475766, and have previously received the investigational product
Have known allergies to LY3475766, related compounds, or any components of the formulation, or history of significant atopy
Have a seated heart rate ≤50 beats per minute
Have clinically significant abnormal electrocardiogram (ECG) results constituting a risk while taking the investigational product, as determined by the investigator
Have an abnormal blood pressure (BP) as determined by the investigator

AdultTrue
ChildFalse
Older AdultTrue

Calculated Values

Sequence:254021200
Number Of Facilities4
Registered In Calendar Year2019
Actual Duration19
Were Results ReportedFalse
Has Us FacilityTrue
Has Single FacilityFalse
Minimum Age Num18
Maximum Age Num65
Minimum Age UnitYears
Maximum Age UnitYears
Number Of Primary Outcomes To Measure1
Number Of Secondary Outcomes To Measure6

Designs

Sequence:30549643
AllocationRandomized
Intervention ModelSequential Assignment
Observational Model
Primary PurposeBasic Science
Time Perspective
MaskingDouble
Subject MaskedTrue
Investigator MaskedTrue

Responsible Parties

Sequence:28915990
Responsible Party TypeSponsor

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A Study Of LY3475766 In Healthy Participants - PlatoHealth (2024)

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