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LY3025876

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Jan 24, 2019

LY3025876 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Feb 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

LY3025876 clinical trials

LY3025876 · 1 trial · 1 indication

Phase 1 1
NCT01870297A Study of LY3025876 in Participants With DiabetesType 2 Diabetes Mellitus
COMPLETED72 Analytics
PHASE1COMPLETED
A Study of LY3025876 in Participants With Diabetes
Type 2 Diabetes MellitusUnlock 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
Predose on Day 1 up to Day 56 in each Part

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876
Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose
PK: Maximum Concentration (Cmax) of LY3025876
Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Predose on Day 7, 14, 28, 56, and 180
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3025876EXPERIMENTALPart A: 0.5 milligram (mg), 1.5 mg, 5 mg, and 15 mg of LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days.
PlaceboPLACEBO_COMPARATORPart B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days
LY3025876 + LiraglutideEXPERIMENTALPart B: 5.0 mg of LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
Placebo + LiraglutidePLACEBO_COMPARATORPart B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.

Interventions

NameTypeDescription
LY3025876DRUGAdministered SQ
PlaceboDRUGAdministered SQ
LiraglutideDRUGAdministered SQ
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Eligibility Criteria

Age Range21 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator, controlled with diet or exercise alone or on a stable dose of metformin for at least 30 days * Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45 kilograms per sq...

Countries:United States
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Frequently asked questions about LY3025876

What is LY3025876?

LY3025876 is an investigational small molecule developed by Eli Lilly and Company for the treatment of Type 2 Diabetes Mellitus. It is a Phase 1 clinical candidate in the metabolic therapeutic area. It has been studied in a single completed Phase 1 trial and is not approved for any use.

What is LY3025876 used for in Type 2 Diabetes Mellitus?

LY3025876 was studied as a potential treatment for Type 2 Diabetes Mellitus. Its only clinical trial enrolled 72 adult participants with diabetes in the United States. Because development remains at Phase 1, LY3025876 is investigational and has no approved indication in Type 2 Diabetes Mellitus or any other condition.

Who makes LY3025876?

LY3025876 is made and developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound in participants with Type 2 Diabetes Mellitus.

What phase is LY3025876 in?

LY3025876 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA or any other regulatory agency for Type 2 Diabetes Mellitus or any other indication.

What clinical trials is LY3025876 in?

LY3025876 has been evaluated in one completed Phase 1 trial, NCT01870297, titled A Study of LY3025876 in Participants With Diabetes. The trial enrolled 72 participants aged 21 years and older in the United States. It was randomized, double-blind, and placebo-controlled, and no trials are currently active.