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LY2608204

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Nov 16, 2018

LY2608204 development status

Highest phase Phase 2 (NCT01408095)
Phase scored for LLYPhase 1
Registered trials 2 across 1 sponsor since Nov 2010

LY2608204 target and mechanism

Molecular targetGCK
Target classActivator
ModalitySmall molecule

Also known as LY2608204 Reference, Glucokinase Activator

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

LY2608204 clinical trials

LY2608204 · 1 trial · 1 indication

Phase 1 1
NCT01247363A Study of LY2608204 in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED20 Analytics
PHASE1COMPLETED
A Study of LY2608204 in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Clinically Significant Adverse Effects
Day 1 through Day 49

Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product.

Secondary Endpoints

Area Under the Concentration Time Curve (AUC)
Predose, 1, 2, 4, 6, 7, 10, 12 and 24 hours Postdose
Maximum Drug Concentration (Cmax)
Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose
Time to Maximum Drug Concentration (Tmax)
Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
LY2608204EXPERIMENTALOral capsules of LY2608204 given once daily at a starting dose of 160 milligram (mg), which may be titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.

Interventions

NameTypeDescription
LY2608204DRUGAdministered orally.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients diagnosed with Type 2 diabetes mellitus (T2DM) who are currently treated with diet/lifestyle measures alone or in combination with anti-diabetic agents, including insulins * Have fasting blood glucose (FBG) greater than or equal to 160 milligram/deciliter (mg/dL), wit...

Countries:United StatesSingapore
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Frequently asked questions about LY2608204

What is LY2608204?

LY2608204 is an investigational small molecule developed by Eli Lilly and Company for the treatment of type 2 diabetes mellitus. It is a glucokinase (GCK) activator that has been studied in early-stage clinical research. The compound is not approved for any indication and remains in Phase 1 development.

What is LY2608204 used for in Diabetes Mellitus, Type 2?

LY2608204 was studied as a potential treatment for type 2 diabetes mellitus, a metabolic condition characterized by elevated blood glucose. It was evaluated in a Phase 1 trial in patients with type 2 diabetes. It is investigational and has not been approved for the treatment of type 2 diabetes or any other condition.

What does LY2608204 target?

LY2608204 targets glucokinase (GCK) and acts as a glucokinase activator. Glucokinase is an enzyme involved in glucose metabolism, and activators of this target are studied for their potential to influence blood glucose regulation in type 2 diabetes. The drug is a small molecule developed by Eli Lilly and Company.

Who is developing LY2608204?

LY2608204 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company sponsored the Phase 1 clinical trial of the compound in patients with type 2 diabetes. Development remains at the Phase 1 stage.

What phase is LY2608204 in?

LY2608204 is in Phase 1 clinical development. It is an investigational agent and is not FDA approved. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled 20 patients with type 2 diabetes.

What clinical trials is LY2608204 in?

LY2608204 has been evaluated in one completed Phase 1 trial, NCT01247363, titled A Study of LY2608204 in Patients With Type 2 Diabetes. The trial enrolled 20 patients across the United States and Singapore. It was an uncontrolled study without randomization or double blinding, and it is now completed.

Is LY2608204 the same as LY2608204 Reference?

LY2608204 Reference is an alternative name used for LY2608204, the investigational glucokinase activator developed by Eli Lilly and Company for type 2 diabetes. Both names refer to the same small molecule compound, which has been studied in a single completed Phase 1 trial.