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LY2922083

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Aug 8, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

LY2922083 · 1 trial · 1 indication

Phase 1 1
NCT01748552A Study of LY2922083 in Healthy Participants and Participants With DiabetesDiabetes Mellitus, Type 2
COMPLETED36 Analytics
PHASE1COMPLETED
A Study of LY2922083 in Healthy Participants and Participants With Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)
Baseline through study completion (up to 70 days)

Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083
Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)
PK: Maximum Concentration (Cmax) of LY2922083
Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)]
Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Placebo (Part A)PLACEBO_COMPARATORSingle oral dose of placebo administered to healthy participants in up to 1 of 3 study periods in Part A
LY2922083 (Part A)EXPERIMENTALSingle ascending dose of LY2922083 (starting at 0.5 milligrams \[mg\]) administered orally to healthy participants in up to 2 of 3 study periods in Part A
Placebo (Part B)PLACEBO_COMPARATORSingle oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B
LY2922083 (Part B)EXPERIMENTALSingle ascending dose of LY2922083 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A

Interventions

NameTypeDescription
PlaceboDRUGAdministered orally as capsules
LY2922083DRUGAdministered orally as capsules
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 18.0 kilograms per square meter (kg/m\^2) * Have blood pressure, pulse rate,...

Countries:Singapore
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Frequently asked questions about LY2922083

What is LY2922083 used for?

LY2922083 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is being developed by Eli Lilly and Company as a potential therapy for this metabolic condition, though it is still in early clinical development and not yet approved.

How does LY2922083 work?

LY2922083 is a small molecule developed by Eli Lilly and Company for Type 2 Diabetes Mellitus. The specific molecular target of LY2922083 has not been disclosed, so its exact mechanism of action is not publicly detailed. It is being evaluated in clinical trials for its potential effects on diabetes.

Who makes LY2922083?

LY2922083 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is an investigational small molecule intended for the treatment of Type 2 Diabetes Mellitus.

What phase is LY2922083 in?

LY2922083 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it remains an investigational drug that has not been approved by regulatory authorities. Further clinical studies would be needed to assess its safety and efficacy.

What clinical trials is LY2922083 in?

LY2922083 has been studied in one completed Phase 1 clinical trial, identified as NCT01748552. This trial, titled "A Study of LY2922083 in Healthy Participants and Participants With Diabetes," enrolled 36 participants with Type 2 Diabetes Mellitus in Singapore. The trial was placebo-controlled and randomized.

Is LY2922083 the same as any other drug?

LY2922083 is an investigational drug candidate developed by Eli Lilly and Company. No alternative names or brand names have been associated with this compound in the available clinical trial information. It is identified solely by its development code LY2922083.