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LY900027

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Aug 5, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04161976A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes MellitusPHASE1 COMPLETED 20 — — Dec 27, 2019Jul 14, 2020Aug 5, 20201 Germany
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)
Day 1 through Day 10 in each dosing period

PK: AUC after Bolus Administration Prior to a MMTT

PK: Maximum Observed Insulin Lispro Concentration (Cmax)
Day 1 through Day 10 in each dosing period

PK: C PK: Cmax

Secondary Endpoints
Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
Day 1 through Day 10 in each dosing period
PD: Total Daily Insulin Dose
Day 1 through Day 10 in each dosing period
Duration Until Catheter Failure
Day -1 through Day 10 in each dosing period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY900027EXPERIMENTALLY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
Insulin LisproACTIVE_COMPARATORInsulin lispro administered to participants with T1DM using CSII in one of two dosing periods.
Interventions
NameTypeDescription
LY900027DRUGLY900027 administered to participants with T1DM using CSII.
Insulin LisproDRUGInsulin lispro administered to participants with T1DM using CSII.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of T1DM for at least 1 year * Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L) * Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²) * Participants should have a glycated hemoglobin of ≤9.0% at screening Exclusion Criteria:

Countries:Germany
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