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LY3457263

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: May 22, 2026

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 Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06897475A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or TirzepatidePHASE2 RECRUITING 240Mar 28, 2025Jan 1, 2027May 22, 202660 United States, Canada +4
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Study Endpoints
Primary Endpoints
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 24
Secondary Endpoints
Change from Baseline in Fasting Serum Glucose
Baseline, Week 24
Percent Change from Baseline in Body Weight
Baseline, Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3457263 Dose 1EXPERIMENTALParticipants will receive LY3457263 subcutaneously (SC)
LY3457263 Dose 2EXPERIMENTALParticipants will receive LY3457263 SC
LY3457263 Dose 3EXPERIMENTALParticipants will receive LY3457263 SC
PlaceboPLACEBO_COMPARATORParticipants will receive placebo SC
Interventions
NameTypeDescription
LY3457263DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites60

Inclusion Criteria: * Have type 2 diabetes * Have HbA1c ≥7.5% to ≤10.5% at screening * Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening * Have had a stable body weight for the three months prior to screening * On stable treatment dose of one of the following incre...

Countries:United StatesCanadaGermanyPolandPuerto RicoUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06897475primaryCompletionDate: changed
LOWMay 24, 2026NCT06897475studyFirstPostDate: changed