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Lispro

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Sep 8, 2025

Target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as Lispro SC

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Lispro · 1 trial · 1 indication

Phase 1 1
NCT02293551A Study of Lispro Formulations in Healthy ParticipantsHealthy Volunteers
COMPLETED54 Analytics
PHASE1COMPLETED
A Study of Lispro Formulations in Healthy Participants
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Study Endpoints

Primary Endpoints

Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])
-30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes

Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: Lispro (A)EXPERIMENTALFormulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.
Part A: Lispro (B)EXPERIMENTALFormulation B: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (C)EXPERIMENTALFormulation C: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (D)EXPERIMENTALFormulation D: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (Reference)EXPERIMENTALReference formulation: Single dose of lispro administered SC in one of five periods.
Part B: LisproEXPERIMENTALFormulation selected from Part A. Single dose of lispro administered SC in one of four periods.

Interventions

NameTypeDescription
LisproDRUGAdministered SC
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: \- Overtly healthy males or females (non-childbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination Exclusion Criteria: \- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L)...

Countries:Singapore
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Frequently asked questions about Lispro

What is Lispro used for?

Lispro is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial to assess its effects in healthy participants.

What does Lispro target?

The molecular target of Lispro has not been disclosed. The drug is a small molecule in early-stage clinical development, and its specific mechanism of action is not publicly available at this time.

Who makes Lispro?

Lispro is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug in healthy volunteers.

What phase is Lispro in?

Lispro is in Phase 1 clinical development. It is an investigational drug that has not been approved by regulatory authorities. The drug is being studied in a Phase 1 trial involving healthy participants.

What clinical trials is Lispro in?

Lispro is being studied in a Phase 1 clinical trial with the identifier NCT02293551. This trial, titled 'A Study of Lispro Formulations in Healthy Participants,' has been completed and enrolled 54 participants in Singapore.

Is Lispro the same as Lispro SC?

Yes, Lispro is also known as Lispro SC. Both names refer to the same investigational drug being developed by Eli Lilly and Company. The drug is currently in Phase 1 clinical trials for healthy volunteers.