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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

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

LY900027 · 1 trial · 1 indication

Phase 1 1
NCT04161976A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes MellitusDiabetes Mellitus, Type 1
COMPLETED20 Analytics
PHASE1COMPLETED
A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1Unlock trial analytics

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 to 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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Frequently asked questions about LY900027

What is LY900027 used for?

LY900027 is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It is administered via an insulin pump. The drug is in Phase 1 clinical development and is not yet approved for any use.

Who makes LY900027?

LY900027 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.

What phase is LY900027 in?

LY900027 is in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug remains investigational and has not been approved by regulatory authorities. Further clinical studies would be needed to assess its potential for approval.

What clinical trials is LY900027 in?

LY900027 has one completed Phase 1 clinical trial, identified as NCT04161976. This study, titled 'A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus,' enrolled 20 participants in Germany. The trial was randomized, double-blind, and active-controlled.

How does LY900027 work?

LY900027 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for use in Type 1 Diabetes Mellitus and is administered through an insulin pump, suggesting it may be designed to work in conjunction with insulin delivery systems.