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LY3025876

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01870297A Study of LY3025876 in Participants With DiabetesPHASE1 COMPLETED 72Jun 1, 2013Dec 1, 2014Jan 24, 20194 United States
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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 — 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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