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LY2189102

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 18, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

LY2189102 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00942188A Study of LY2189102 in Patients With Type 2 DiabetesType 2 Diabetes
COMPLETED106 Analytics
PHASE2COMPLETED
A Study of LY2189102 in Patients With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks
Baseline, 12 weeks

Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.

Number of Participants With Adverse Events (AEs)
Baseline up to Day 98

Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Secondary Endpoints

Change From Baseline in Fasting Glucose at 12 Weeks
Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks
Baseline, 12 weeks
Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks
Baseline, 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
0.6 milligrams (mg) LY2189102EXPERIMENTAL -
18 mg LY2189102EXPERIMENTAL -
180 mg LY2189102EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR0.9% Sodium Chloride
Part A LY2189102 0.1 mg/kg/wkEXPERIMENTALPart A: 2 times (x) 0.1 milligrams/kilogram/week (mg/kg/wk) Loading dose, then 0.1 mg/kg/wk) X 4 weeks (wks), intravenous (IV) Part B: 2 x 0.02 mg/kg/wk Loading dose, then 0.02 mg/kg/wk X 4 wks, IV
Part A LY2189102 0.3 mg/kg/wkEXPERIMENTALPart A: 2 x 0.3 mg/kg/wk Loading dose, then 0.3 mg/kg/wk X 4 wks, IV Part B: 2 x 0.15 mg/kg/wk Loading dose, then 0.15 mg/kg/wk X 4 wks, IV
Part A LY2189102 1.0 mg/kg/wkEXPERIMENTALPart A: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV Part B: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV
Part A LY2189102 2.5 mg/kg/wkEXPERIMENTALPart A: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV Part B: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV

Interventions

NameTypeDescription
LY2189102DRUGParticipants received 2 subcutaneous (SC) injections weekly for 12 weeks.
PlaceboDRUGParticipants received 2 SC injections weekly for 12 weeks.
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter \[ng/ml\]), with duration of more than 3 months. * Body mass index between 25 and 40 kilograms per square meter (kg/m2). * Stable on diet and exercise alone, wi...

Countries:United StatesPoland
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Frequently asked questions about LY2189102

What is LY2189102 used for?

LY2189102 is an investigational small molecule being studied for Type 2 Diabetes and Rheumatoid Arthritis. It is being developed by Eli Lilly and Company. The drug is in clinical development, with completed trials in both indications, but it is not approved and remains investigational.

What does LY2189102 target?

LY2189102 is a small molecule developed by Eli Lilly and Company. Its molecular target has not been specified in available data. The drug is being studied for Type 2 Diabetes and Rheumatoid Arthritis, but its mechanism of action is not disclosed.

Who makes LY2189102?

LY2189102 is developed by Eli Lilly and Company, traded on the NYSE under the ticker LLY. The company is conducting clinical trials for this investigational small molecule in Type 2 Diabetes and Rheumatoid Arthritis.

What phase is LY2189102 in?

LY2189102 is in clinical development. A Phase 1 trial for Rheumatoid Arthritis and a Phase 2 trial for Type 2 Diabetes have both been completed. The drug is investigational and not approved for any use.

What clinical trials is LY2189102 in?

LY2189102 has two completed trials. NCT00380744 was a Phase 1 safety and pharmacokinetics study in Rheumatoid Arthritis with 121 participants. NCT00942188 was a Phase 2 study in Type 2 Diabetes with 106 participants. Both trials are completed.

Is LY2189102 the same as any other drug?

LY2189102 is the only name provided for this investigational drug. No alternative names have been reported. It is being studied by Eli Lilly and Company for Type 2 Diabetes and Rheumatoid Arthritis.