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LY2608204

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

LY2608204 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It has also been evaluated in healthy volunteers to compare different formulations. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes LY2608204?

LY2608204 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting early-stage clinical trials to evaluate the safety and tolerability of this investigational compound.

What phase is LY2608204 in?

LY2608204 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in patients with Type 2 Diabetes and another in healthy volunteers. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is LY2608204 in?

LY2608204 has been studied in two completed Phase 1 trials. NCT01247363 enrolled 20 patients with Type 2 Diabetes in the United States and Singapore. NCT01313286 enrolled 16 healthy volunteers in Singapore to compare two forms of the drug. Both trials are completed.

Is LY2608204 the same as any other drug?

LY2608204 is the code name used by Eli Lilly for this investigational compound. No alternative brand names or other designations have been disclosed in the clinical trial information. The drug is identified solely by its LY2608204 designation in the studies.