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LY3541105

Phase 1

Overweight | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 27, 2025

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 Enrollment206
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05380323A Study of LY3541105 in Healthy and Overweight ParticipantsPHASE1 COMPLETED 206 — — May 10, 2022Aug 27, 2024Jun 27, 20252 United States
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Predose up to 26 weeks

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), 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 LY3541105
Predose through day 43 (Part A) & day 78 (Part B)
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
Predose through day 43 (Part A) & day 78 (Part B)
PK: Maximum Observed Concentration (Cmax) of LY3541105
Predose through day 43 (Part A) & day 78 (Part B)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3541105 (Part A)EXPERIMENTALSingle ascending doses of LY3541105 administered subcutaneously (SC).
LY3541105 (Part B)EXPERIMENTALMultiple ascending doses of LY3541105 administered SC.
LY3541105 (Part C)EXPERIMENTALEscalating doses of LY3541105 administered SC.
Placebo (Part A)PLACEBO_COMPARATORPlacebo administered SC.
Placebo (Part B)PLACEBO_COMPARATORPlacebo administered SC.
Placebo (Part C)PLACEBO_COMPARATORPlacebo administered SC.
Interventions
NameTypeDescription
LY3541105DRUGAdministered SC.
PlaceboDRUGAdministered SC.
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation * Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential * Have a body mass index (BMI) in the range of greater t...

Countries:United States
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