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LY3372689

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 20, 2023

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 Trials5
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05749848A Study of Carbon-14-Labelled [14C] LY3372689 in Healthy Male ParticipantsPHASE1 COMPLETED 8 — — Feb 24, 2023Apr 18, 2023Apr 20, 20231 United States
NCT04392271A Study of the Effects of Multiple Doses of LY3372689 on the Brain in Healthy ParticipantsPHASE1 COMPLETED 4 — — Aug 6, 2020Oct 14, 2020Nov 4, 20201 United States
NCT04106206A Safety Study of LY3372689 in Healthy ParticipantsPHASE1 COMPLETED 54 — — Oct 23, 2019Feb 12, 2020Apr 24, 20201 United States
NCT03944031A Study of the Effects of LY3372689 on the Brain in Healthy ParticipantsPHASE1 COMPLETED 17 — — May 8, 2019Feb 19, 2020Apr 22, 20201 United States
NCT03819270A Safety Study of LY3372689 Given By Mouth to Healthy ParticipantsPHASE1 COMPLETED 23 — — Feb 5, 2019Jun 24, 2019Jul 5, 20191 United States
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Study Endpoints
Primary Endpoints
Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to Day 17 post dose
Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to Day 17 post dose
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
Approximately 2 to 96 hours following the first dose

Percent OGA EO

Percent OGA EO
Approximately 2 to 96 hours following the last dose
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration
Baseline through final follow-up at approximately Day 30

A summary of 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-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689
Predose up to Day 17 post dose
PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689
Predose up to Day 17 post dose
PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689
Predose up to Day 17 post dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[¹⁴C]-LY3372689EXPERIMENTALSingle dose of \[¹⁴C\]-LY3372689 administered orally.
LY3372689 + [18F]LSN3316612EXPERIMENTALLY3372689 administered orally followed by \[18F\]LSN3316612 PET tracer administered intravenously (IV) approximately 24 hours later.
LY3372689EXPERIMENTALLY3372689 administered orally
PlaceboPLACEBO_COMPARATORPlacebo administered orally
Interventions
NameTypeDescription
[¹⁴C]-LY3372689DRUGAdministered orally.
LY3372689DRUGAdministered orally.
[18F]LSN3316612DIAGNOSTIC_TESTAdministered intravenously (IV).
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participants who are overtly healthy as determined by medical evaluation * Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²) * Males who agree to use highly effective/effective methods of contraception for 14 weeks following the dose...

Countries:United States
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