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LY3325656

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Aug 23, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

LY3325656 · 1 trial · 1 indication

Phase 1 1
NCT03115099A Study of LY3325656 in Healthy Participants and Participants With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED80 Analytics
PHASE1COMPLETED
A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656
Baseline up to 72 hours after each dose of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Baseline up to 72 hours after each dose of study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Placebo (Part A)PLACEBO_COMPARATORSingle oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A
LY3325656 (Part A)EXPERIMENTALSingle ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A
Placebo (Part B)PLACEBO_COMPARATORSingle oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B
LY3325656 (Part B)EXPERIMENTALSingle oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B
Liraglutide (Part B)ACTIVE_COMPARATORSingle subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B
LY3325656 + Sitagliptin (Part B)EXPERIMENTALSingle oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B

Interventions

NameTypeDescription
LY3325656DRUGAdministered orally
PlaceboDRUGAdministered orally
LiraglutideDRUGAdministered subcutaneously
SitagliptinDRUGAdministered orally
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Eligibility Criteria

Age Range21 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: For all participants: * Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes * Have a screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²) * Have blood pressure, pulse rate, bl...

Countries:Singapore
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Frequently asked questions about LY3325656

What is LY3325656 used for?

LY3325656 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial involving healthy participants and those with Type 2 Diabetes.

Who makes LY3325656?

LY3325656 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for the treatment of Type 2 Diabetes Mellitus.

What phase is LY3325656 in?

LY3325656 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Type 2 Diabetes Mellitus, with one completed Phase 1 trial involving 80 participants.

What clinical trials is LY3325656 in?

LY3325656 has one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT03115099. The study, titled "A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes," enrolled 80 participants in Singapore and included healthy volunteers.

Is LY3325656 FDA approved?

LY3325656 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Type 2 Diabetes Mellitus. The drug has completed one Phase 1 trial, but it remains in clinical development and has not received regulatory approval.