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LY900014-U200

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 1, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment118

FDA Designations

No designations recorded

Clinical trial landscape

LY900014-U200 · 2 trials · 1 indication

Phase 1 2
NCT03616977Study to Compare 2 Formulations of LY900014 in Healthy ParticipantsHealthy
COMPLETED69 Analytics
NCT03334448A Study to Compare 2 Formulations of LY900014 in Healthy ParticipantsHealthy
COMPLETED49 Analytics
PHASE1COMPLETED
Study to Compare 2 Formulations of LY900014 in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study to Compare 2 Formulations of LY900014 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm
Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose

Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.

Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10])
Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours)

Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC\[0-10h\])

Secondary Endpoints

Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm
Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm
Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY900014 U-200EXPERIMENTALSingle subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.
LY900014 U-100EXPERIMENTALSingle SC dose of LY900014 U-100 in two of four study periods.
LY900014-U200EXPERIMENTALSingle subcutaneous (SC) dose of 15 units (U) LY900014 U-200 in two of four study periods
LY900014-U100EXPERIMENTALSingle SC dose of 15 U LY900014 U-100 in two of four study periods

Interventions

NameTypeDescription
LY900014 U-200DRUGAdministered SC
LY900014 U-100DRUGAdministered SC
LY900014-U200DRUGAdministered SC
LY900014-U100DRUGAdministered SC
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Eligibility Criteria

Age Range21 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: \- Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²) * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laborat...

Countries:Singapore
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Frequently asked questions about LY900014-U200

What is LY900014-U200 used for?

LY900014-U200 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with two completed trials evaluating the drug in healthy volunteers. The drug is not approved and remains under investigation.

Who makes LY900014-U200?

LY900014-U200 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy participants.

What phase is LY900014-U200 in?

LY900014-U200 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy participants. The drug is investigational and has not been approved for any use.

What clinical trials is LY900014-U200 in?

LY900014-U200 has been studied in two completed Phase 1 trials: NCT03334448, which enrolled 49 healthy participants, and NCT03616977, which enrolled 69 healthy participants. Both trials were conducted in Singapore and compared two formulations of the drug.

Is LY900014-U200 the same as LY900014?

LY900014-U200 is a designation for a specific formulation or version of the drug LY900014. The clinical trials listed for LY900014-U200 compare two formulations of LY900014 in healthy participants, indicating that LY900014-U200 is one of the formulations being tested.