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LY4057996

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 11, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06945406A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 DiabetesPHASE1 RECRUITING 124May 16, 2025Dec 1, 2026Mar 11, 20261 Germany
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to Study Completion (Up to 47 Weeks)

A summary of SAEs and 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 LY4057996
Baseline to Study Completion (Up to 47 Weeks)
PK: Maximum Concentration (Cmax) of LY4057996
Baseline to Study Completion (Up to 47 Weeks)
Pharmacodynamic (PD): Change from Baseline in Fasting Glucose
Baseline to Study Completion (Up to 47 Weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4057996 Part A (Cohorts A1-A5)EXPERIMENTALLY4057996 administered subcutaneously (SC) and/or intravenously (IV)
Placebo Part A (Cohort A1-A5)PLACEBO_COMPARATORPlacebo administered SC and/or IV
LY4057996 Part BEXPERIMENTALLY4057996 administered SC
LY4057996 Part CEXPERIMENTALLY4057996 and interventions of pre-study basal insulin and Lispro administered SC
Degludec Part A (Cohort A2-A5)ACTIVE_COMPARATORDegludec administered SC and/or IV
Degludec Part BACTIVE_COMPARATORDegludec administered SC
Interventions
NameTypeDescription
LY4057996 SCDRUGAdministered SC
LY4057996 IVDRUGAdministered IV
Placebo SCDRUGAdministered SC
Placebo IVDRUGAdministered IV
Degludec SCDRUGAdministered SC
Lispro SCDRUGAdministered SC
Degludec IVDRUGAdministered IV
Pre-study basal insulin SCDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Part A for Healthy Participants: * Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment Part A for Type 2 Diabetes (T2DM) Participants: * Are participants with T2DM diagnosed grea...

Countries:Germany
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06945406primaryCompletionDate: changed
LOWMay 24, 2026NCT06945406studyFirstPostDate: changed