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LY3938577

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 13, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

LY3938577 · 3 trials · 4 indications

Phase 2 1Phase 1 2
NCT07215312A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal InsulinDiabetes Mellitus, Type 2
ACTIVE NOT_RECRUITING100 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)
Baseline through Week 20
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration.
Baseline up to Approximately Week 11

A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Part B and D: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration.
Baseline up to Week 10

A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Baseline up to Week 10
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Baseline up to Week 10
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
Predose on day 1 up to week 13 post dose

PK: AUC of LY3938577 for intravenous administration

Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
Predose on day 1 up to week 13 post dose

PK: AUC of LY3938577

Part C: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
Predose on day 1 up to week 13 post dose

PK: AUC of LY3938577 for SC administration

Part D: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
Predose on day 1 up to week 13 post dose

PK: AUC of LY3938577 for SC administration

Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577
Predose on day 1 up to week 13 post dose

PK: Cmax of LY3938577

Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577
Predose on day 1 up to week 13 post dose

PK: Cmax of LY3938577

Part C: PK: Concentration of LY3938577
Predose on day 1 up to week 13 post dose
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Baseline up to 16 days

A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Baseline up to 44 days

A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Part A: Incidence of Hypoglycemia
Baseline up to 16 days
Part B: Incidence of Hypoglycemia
Baseline up to 44 days

Secondary Endpoints

Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis)
Baseline through Week 20
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 20
Pharmacokinetics (PK): Average Concentration of LY3938577
Baseline through Week 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3938577EXPERIMENTALParticipants will receive LY3938577 subcutaneously (SC)
DegludecACTIVE_COMPARATORParticipants will receive degludec SC
Part A Period 1: LY3938577EXPERIMENTALSingle dose of LY3938577 administered intravenously (IV) in healthy participants.
Part A Period 1: PlaceboPLACEBO_COMPARATORSingle dose of Placebo administered intravenously (IV) in healthy participants.
Part B: LY3938577EXPERIMENTALFor each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of LY3938577 administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level.
Part B: Insulin DegludecACTIVE_COMPARATORFor each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of Insulin Degludec administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level.
Part C: LY3938577EXPERIMENTALLY3938577 administered subcutaneously (SC)
Part C: Insulin DegludecACTIVE_COMPARATORInsulin Degludec administered subcutaneously (SC)
Part A Period 2: LY3938577EXPERIMENTALSequential dose of LY3938577 administered subcutaneously (SC).
Part A Period 2: PlaceboPLACEBO_COMPARATORSequential dose of Placebo administered subcutaneously (SC)
Part D Period 1: Basal Insulin and Lispro Prandial InsulinOTHERPre-study basal insulin (provided by patient) and lispro prandial insulin administered SC
Part D Period 2: Lispro Prandial Insulin and LY3938577EXPERIMENTALLispro prandial insulin and LY3938577 administered SC
LY3938577 (Part A)EXPERIMENTALLY3938577 administered Subcutaneously (SC).
Placebo (Part A)PLACEBO_COMPARATORPlacebo administered SC.
Insulin degludec (Part A)ACTIVE_COMPARATORInsulin degludec administered SC.
LY3938577 (Part B)EXPERIMENTALLY3938577 administered SC.
Insulin degludec (Part B)ACTIVE_COMPARATORInsulin degludec administered SC.

Interventions

NameTypeDescription
LY3938577DRUGAdministered SC
DegludecDRUGAdministered SC
PlaceboDRUGAdministered Intravenously (IV)
Insulin DegludecDRUGAdministered Intravenously (IV)
Insulin LisproDRUGAdministered Intravenously (IV)
Basal InsulinDRUGAdministered subcutaneously (SC)
Lispro Prandial InsulinDRUGAdministered subcutaneously (SC)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Have type 2 diabetes * Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening * Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive * Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)...

Countries:United StatesArgentinaGermany
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Recent Changes (Last 90 Days)

MEDIUMJul 13, 2026NCT07215312Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 13, 2026NCT07215312Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 23, 2026NCT07215312lastUpdatePostDate: changed
LOWJun 23, 2026NCT07215312lastUpdatePostDate: changed

Frequently asked questions about LY3938577

What is LY3938577 used for?

LY3938577 is an investigational small molecule being studied for metabolic conditions, including Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, as well as in healthy participants. It is being developed by Eli Lilly and Company and is currently in Phase 2 clinical development.

How does LY3938577 work?

LY3938577 is a small molecule being developed by Eli Lilly and Company for metabolic diseases. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its effects on glucose control in patients with diabetes.

Who makes LY3938577?

LY3938577 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule in clinical development for metabolic conditions.

What phase is LY3938577 in?

LY3938577 is currently in Phase 2 clinical development. It has completed a Phase 1 study in healthy participants and those with Type 2 Diabetes Mellitus, and an additional Phase 1 study is recruiting participants. The drug is not yet approved and remains investigational.

What clinical trials is LY3938577 in?

LY3938577 has been studied in three clinical trials. NCT06132126, a completed Phase 1 study in healthy participants and those with Type 2 Diabetes, enrolled 66 participants. NCT06280703, a recruiting Phase 1 study in healthy participants and those with Type 1 Diabetes, aims to enroll 118. NCT07215312, an active Phase 2 study in Type 2 Diabetes patients previously treated with basal insulin, targets 100 participants.

Is LY3938577 the same as any other drug?

No alternative names for LY3938577 have been reported. The drug is identified solely by its code name LY3938577 in clinical trial registrations and is being developed by Eli Lilly and Company for metabolic conditions.