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LY4057996

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 11, 2026

Target and mechanism

ModalitySmall molecule

Also known as LY4057996 SC

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

LY4057996 · 1 trial · 2 indications

Phase 1 1
NCT06945406A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 DiabetesDiabetes Mellitus, Type 1
RECRUITING124 Analytics
PHASE1RECRUITING
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Diabetes Mellitus, Type 1
NCT06945406124
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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 to 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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Frequently asked questions about LY4057996

What is LY4057996 used for?

LY4057996 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes LY4057996?

LY4057996 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY.

What phase is LY4057996 in?

LY4057996 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use.

What clinical trials is LY4057996 in?

LY4057996 is being studied in a Phase 1 trial with the identifier NCT06945406. This trial is recruiting participants with Type 1 and Type 2 Diabetes, as well as healthy volunteers, and is being conducted in Germany.

Is LY4057996 the same as LY4057996 SC?

Yes, LY4057996 is also known as LY4057996 SC. Both names refer to the same investigational drug being developed by Eli Lilly and Company.