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LY3493269

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jan 14, 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 Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04515576A Study of LY3493269 in Participants With Type 2 DiabetesPHASE1 COMPLETED 56Aug 25, 2020Mar 9, 2021Jan 14, 20253 United States
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Study Endpoints
Primary Endpoints
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through final follow-up at Day 57

TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. A summary of SAEs, TEAEs 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 From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose
Baseline, Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1.5 milligrams (mg) DulaglutideACTIVE_COMPARATORParticipants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.
0.3 mg LY3493269EXPERIMENTALParticipants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
1 mg LY3493269EXPERIMENTALParticipants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
0.75/1.5/3 mg LY3493269EXPERIMENTALParticipants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
1.5/3/4/5 mg LY3493269EXPERIMENTALParticipants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
PlaceboPLACEBO_COMPARATORParticipants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
Interventions
NameTypeDescription
LY3493269DRUGAdministered SC
DulaglutideDRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Are male or female not of childbearing potential * Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening * Have had a stable body weight (\<5% body weight change) for the 3 months prior to screening * Have not modified their diet or ado...

Countries:United States
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