Recent Updates
Recently added Catalysts

LY3009385

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Oct 6, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

LY3009385 · 1 trial · 1 indication

Phase 1 1
NCT01477567A First-in-Human Study of LY3009385 in Healthy ParticipantsDiabetes Mellitus, Type 2
COMPLETED40 Analytics
PHASE1COMPLETED
A First-in-Human Study of LY3009385 in Healthy Participants
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
Baseline through Day 28

The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Endpoints

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385
Predose through Day 28
Pharmacokinetics: Maximum Concentration (Cmax)
Predose through Day 28
Change in Level of Blood Glucose Before and After a Standard Meal
Baseline, Day 5, and Day 14
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
0.3 mg LY3009385EXPERIMENTALLY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
1 mg LY3009385EXPERIMENTALLY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
3 mg LY3009385EXPERIMENTALLY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
9 mg LY3009385EXPERIMENTALLY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
22 mg LY3009385EXPERIMENTALLY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
54 mg LY3009385EXPERIMENTALLY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
PlaceboPLACEBO_COMPARATORPlacebo: saline, subcutaneous (SC) injection, single dose on Day 1

Interventions

NameTypeDescription
LY3009385DRUG -
PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are a healthy male or a female who cannot become pregnant * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2) at screening * Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study * Have vei...

Countries:Singapore
Unlock Eligibility Criteria

Frequently asked questions about LY3009385

What is LY3009385 used for?

LY3009385 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is being developed by Eli Lilly and Company and is currently in Phase 1 clinical development.

What does LY3009385 target?

The specific molecular target of LY3009385 has not been disclosed. It is a small molecule being investigated for its potential role in treating Type 2 Diabetes Mellitus, but its mechanism of action is not publicly available.

Who makes LY3009385?

LY3009385 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials.

What phase is LY3009385 in?

LY3009385 is in Phase 1 clinical development. It has completed one first-in-human study in healthy participants, and it remains an investigational drug that has not been approved by regulatory authorities.

What clinical trials is LY3009385 in?

LY3009385 has one completed Phase 1 trial, NCT01477567, titled 'A First-in-Human Study of LY3009385 in Healthy Participants.' This randomized, double-blind, placebo-controlled study enrolled 40 participants in Singapore and included healthy volunteers.

Is LY3009385 the same as any other drug?

No alternative names for LY3009385 have been disclosed. It is identified solely by its development code LY3009385 and is not known to be marketed under any other name.