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LY4292009

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 17, 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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06977880A Phase 1, First-in-human Study of MORF-440 (LY4292009) in Healthy ParticipantsPHASE1 COMPLETED 80 — — Feb 19, 2025Mar 20, 2026Apr 17, 20261 Canada
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
Baseline to Study Completion (Up to Day 17)
Percentage of Participants with TEAEs and SAEs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
Baseline to Study Completion (Up to Day 7)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) in (Cohort A1-A6) and MAD (Cohort B1-B4)
Baseline to Study Completion (Up to Day 7)
Change from Baseline in Laboratory Parameter and Vital Signs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
Baseline to Study Completion (Up to Day 7)
Number of Participants with Clinically Significant Changes in Cardiovascular Evaluation in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
Baseline to Study Completion (Up to Day 7)
Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
SAD Cohorts: Predose up to Day 4 Postdose
PK: Time to Maximum Concentration (Tmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
SAD Cohorts: Predose up to Day 4 Postdose
PK: Area Under the Concentration Curve (AUC) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
SAD Cohorts: Predose up to Day 4 Postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort A1EXPERIMENTALParticipants received LY4292009 orally.
Cohort A2EXPERIMENTALParticipants received LY4292009 orally.
Cohort A3EXPERIMENTALParticipants received LY4292009 orally.
Cohort A4EXPERIMENTALParticipants received LY4292009 orally.
Cohort A5EXPERIMENTALParticipants received LY4292009 orally.
Cohort A6 (Optional)EXPERIMENTALParticipants received LY4292009 orally.
Cohort B1EXPERIMENTALParticipants received LY4292009 orally.
Cohort B2EXPERIMENTALParticipants received LY4292009 orally.
Cohort B3EXPERIMENTALParticipants received LY4292009 orally.
Cohort B4 (Optional)EXPERIMENTALParticipants received LY4292009 orally.
PlaceboPLACEBO_COMPARATORParticipants receive placebo.
Interventions
NameTypeDescription
LY4292009DRUGAdministered orally
PlaceboDRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive * If male, meets one of the following: * can procreate and agree to use one of the accepted to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to...

Countries:Canada
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06977880TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06977880studyFirstPostDate: changed