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LY3985297

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Sep 11, 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 Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06395012A First-In-Human Study of LY3985297 in Healthy ParticipantsPHASE1 COMPLETED 140Jun 7, 2024Aug 6, 2025Sep 11, 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
Baseline up to Week 13 (Part A), Week 17 (Part B)

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): Maximum Observed Concentration (Cmax) of LY3985297 following intravenous (IV) administration
Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
PK: Cmax of LY3985297 following subcutaneous (SC) administration
Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985297 following IV administration
Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A: LY3985297 (Cohorts 1-8)EXPERIMENTALSingle ascending dose of LY3985297 administered either intravenously (IV) or subcutaneously (SC). Cohort 5,6 and 7 is conducted in Japanese or Chinese participants.
Part B: LY3985297 (Cohorts 1-4)EXPERIMENTALMultiple ascending dose of LY3985297 administered either IV or SC.
Placebo Comparator: Part A and B: PlaceboPLACEBO_COMPARATORPlacebo administered either IV or SC.
Interventions
NameTypeDescription
LY3985297DRUGAdministered either IV or SC.
PlaceboDRUGAdministered either IV or SC.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants must be overtly healthy, as determined by medical evaluation. * Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, and a minimum body weight of 45.0 kg. * Participants must be assigned male or female at birth and not of childbear...

Countries:United States
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