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LY4086940

Phase 1

Healthy | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: May 12, 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 Enrollment216
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06945419A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 DiabetesPHASE1 RECRUITING 216Apr 23, 2025Jul 1, 2026May 12, 20265 United States, Singapore
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to Week 9
Secondary Endpoints
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940
Predose up to Day 64
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940
Predose up to Day 64
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A: LY4086940 Single Dose (Healthy Participants)EXPERIMENTALParticipants will receive a single dose of LY4086940 orally
Part A: Placebo Single Dose (Healthy Participants)PLACEBO_COMPARATORParticipants will receive a single dose of placebo orally
Part A: LY4086940 Multiple Dose (Healthy Participants)EXPERIMENTALParticipants will receive LY4086940 orally for 3 days
Part A: Placebo Multiple Dose (Healthy Participants)PLACEBO_COMPARATORParticipants will receive placebo orally for 3 days
Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity)EXPERIMENTALParticipants will receive LY4086940 orally for 4 weeks
Part B: Placebo Multiple Dose (Participants with Overweight or Obesity)PLACEBO_COMPARATORParticipants will receive placebo orally for 4 weeks
Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity)EXPERIMENTALParticipants will receive LY4086940 orally for 4 weeks
Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or ObesityPLACEBO_COMPARATORParticipants will receive placebo orally for 4 weeks
Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)EXPERIMENTALParticipants will receive LY4086940 orally for 4-6 weeks
Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)PLACEBO_COMPARATORParticipants will receive placebo orally for 4-6 weeks
Part E (Open-Label): LY4086940 Single Dose (Healthy Participants)EXPERIMENTALParticipants will receive a single dose of LY4086940 intravenously (IV)
Interventions
NameTypeDescription
LY4086940DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Have no significant body weight change for the 3 months prior to screening Part A and Part E: * Are considered healthy * Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at screening Part B: * Have a BMI of 27 to 45 kg/m2 at screening Part C: *...

Countries:United StatesSingapore
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06945419Enrollment: 201 → 216
LOWMay 24, 2026NCT06945419studyFirstPostDate: changed