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LY4167586

Phase 1

Overweight | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 9, 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 Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07225556A Study of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise HealthyPHASE1 RECRUITING 84 — — Nov 18, 2025Dec 1, 2026Mar 9, 20262 United States, Singapore
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Study Endpoints
Primary Endpoints
Number and Incidence of Serious Adverse Events (SAEs)
Baseline to study completion (up to 29 weeks)

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

Secondary Endpoints
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)
Predose on Day 1 through end of the Follow-up Period (Week 25)
PK: Time of Maximum Drug Concentration (tmax)
Predose on Day 1 through end of the Follow-up Period (Week 25)
PK: Area Under the Concentration Versus Time Curve (AUC)
Predose on Day 1 through end of the Follow-up Period (Week 25)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4167586 (Cohorts A1 to A6)EXPERIMENTALLY4167586 administered subcutaneously (SC)
LY4167586 (Cohorts A1 to A6) PlaceboPLACEBO_COMPARATORLY4167586 administered SC
LY4167586 (Cohort B)EXPERIMENTALLY4167586 administered intravenously (IV)
Interventions
NameTypeDescription
LY4167586DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participant must be 21 for Singapore site * Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive * Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent \[%\] body weight chang...

Countries:United StatesSingapore
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07225556primaryCompletionDate: changed
LOWMay 24, 2026NCT07225556studyFirstPostDate: changed