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LY4064912

Phase 1

Overweight or Obesity | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Apr 20, 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 Enrollment144
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07152002A Study of LY4064912 in Healthy Participants and With Overweight or ObesityPHASE1 RECRUITING 144Aug 28, 2025Nov 1, 2026Apr 20, 20263 United States, Singapore
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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
Postdose to Approximately Week 27

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912
Predose Up to Day 78
PK: Maximum Concentration (Cmax) of LY4064912
Predose Up to Day 78
Change from Baseline in Body Weight
Baseline to Approximately Week 27
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A: LY4064912 (Cohorts 1-6)EXPERIMENTALLY4064912 administered subcutaneously (SC)
Part A: LY4064912 (Cohort 6a)EXPERIMENTALLY4064912 administered intravenously (IV)
Part A: PlaceboPLACEBO_COMPARATORPlacebo administered SC and IV
Part B: LY4064912 (Cohorts 7-10)EXPERIMENTALLY4064912 administered SC
Part B: PlaceboPLACEBO_COMPARATORPlacebo administered SC
Part C: LY4064912 (Cohort 11)EXPERIMENTALLY4064912 administered SC
Part C: PlaceboEXPERIMENTALPlacebo administered SC
Interventions
NameTypeDescription
LY4064912DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Age is 21-65 years old at Singapore Sites * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring Part A: Body Mass Index (BMI) within the range greater than or equal ...

Countries:United StatesSingapore
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07152002primaryCompletionDate: changed
LOWMay 24, 2026NCT07152002studyFirstPostDate: changed