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LY3025876

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 24, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

LY3025876 · 2 trials · 2 indications

Phase 1 2
NCT01870297A Study of LY3025876 in Participants With DiabetesType 2 Diabetes Mellitus
COMPLETED72 Analytics
NCT01528124A Study of LY3025876 in Healthy VolunteersHealthy Volunteers
COMPLETED41 Analytics
PHASE1COMPLETED
A Study of LY3025876 in Participants With Diabetes
Type 2 Diabetes MellitusUnlock trial analytics
PHASE1COMPLETED
A Study of LY3025876 in Healthy Volunteers
Healthy VolunteersUnlock 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.

Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events
Baseline up to 28 days post-dose

Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.

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 StatesSingapore
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Frequently asked questions about LY3025876

What is LY3025876 used for?

LY3025876 is an investigational small molecule being studied for Type 2 Diabetes Mellitus and in healthy volunteers. It is in Phase 1 clinical development and is not approved by the FDA. Eli Lilly and Company (NYSE: LLY) is developing this drug.

What does LY3025876 target?

LY3025876 is a small molecule being developed by Eli Lilly and Company. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its effects in Type 2 Diabetes Mellitus and in healthy volunteers.

Who makes LY3025876?

LY3025876 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug is currently in Phase 1 clinical trials for Type 2 Diabetes Mellitus and healthy volunteer studies.

What phase is LY3025876 in?

LY3025876 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Eli Lilly and Company is conducting early-stage trials to evaluate its safety and tolerability in healthy volunteers and in participants with Type 2 Diabetes Mellitus.

What clinical trials is LY3025876 in?

LY3025876 has been studied in two completed Phase 1 trials. NCT01528124 enrolled 41 healthy volunteers in Singapore, and NCT01870297 enrolled 72 participants with Type 2 Diabetes Mellitus in the United States. Both trials were randomized, double-blind, and placebo-controlled.

Is LY3025876 the same as another drug?

LY3025876 is the investigational code name for this drug developed by Eli Lilly and Company. No alternative brand names or other designations have been publicly associated with this compound in the clinical trial information available.