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-LY3437943

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 18, 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 Trials6
Total Enrollment266
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06003465A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection DevicesPHASE1 COMPLETED 57 — — Aug 29, 2023Feb 8, 2024Mar 29, 20243 United States
NCT05959096A Study of LY3437943 in Healthy Participants With a High Body Mass IndexPHASE1 COMPLETED 85 — — Jul 18, 2023Jul 25, 2024Oct 1, 20241 United States
NCT05916560A Study of LY3437943 in Participants With Impaired and Normal Liver FunctionPHASE1 COMPLETED 43 — — Jul 13, 2023Mar 2, 2025Apr 18, 20255 United States
NCT05757531A Study of Carbon-14-Labelled [14C] LY3437943 in Healthy Male ParticipantsPHASE1 COMPLETED 7 — — Mar 17, 2023Jun 23, 2023Jul 5, 20231 United States
NCT05611957A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal FunctionPHASE1 COMPLETED 29 — — Nov 16, 2022Sep 5, 2023Oct 2, 20234 United States
NCT03841630A Safety Study of LY3437943 Given as a Single Injection in Healthy ParticipantsPHASE1 COMPLETED 45 — — Mar 13, 2019Jul 25, 2019Aug 6, 20191 Singapore
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
Predose up to 43 days postdose

PK: Cmax of LY3437943

PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943
Predose up to 43 days postdose

PK: AUC\[0-tlast\] of LY3437943

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
Predose up to 43 days postdose

PK: AUC(0-∞) of LY3437943

Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
Predose on Day 1 up to 43 days postdose (Part A)

Part A: PK: AUC(0-∞) of LY3437943

Part A: PK: Maximum Concentration (Cmax) of LY3437943
Predose on Day 1 up to 43 days postdose (Part A)

Part A: PK: Cmax of LY3437943

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
Predose up to 30 days postdose

PK: AUC0-∞ of LY3437943

PK: Maximum observed concentration (Cmax) of LY3437943
Predose up to 30 days postdose

PK: Cmax of LY3437943

Urinary Excretion of LY3437943 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to 63 days post dose
Fecal Excretion of LY3437943 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to 63 days post dose
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through final follow-up at approximately Day 43

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

Secondary Endpoints
Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
Predose on Day 1 up to 71 days postdose (Part B)
Part B: PK: Maximum Concentration (Cmax) of LY3437943
Predose on Day 1 up to 71 days postdose (Part B)
PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3437943
Predose up to 63 days post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3437943 - TestEXPERIMENTALA single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)
LY3437943 - ReferenceACTIVE_COMPARATORA single dose of LY3437943 administered by SC injection via a reference device (reference formulation)
LY3437943 (Part A)EXPERIMENTALLY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen
LY3437943 (Part B)EXPERIMENTALLY3437943 administered intravenously (IV)
LY3437943 (Normal Hepatic Function)EXPERIMENTALLY3437943 administered subcutaneously (SC).
LY3437943 (Severe Hepatic Impairment)EXPERIMENTALLY3437943 administered SC.
LY3437943 (Moderate Hepatic Impairment)EXPERIMENTALLY3437943 administered SC.
LY3437943 (Mild Hepatic Impairment)EXPERIMENTALLY3437943 administered SC.
[¹⁴C]-LY3437943EXPERIMENTALSingle dose of \[¹⁴C\]-LY3437943 administered subcutaneously (SC).
LY3437943 (Control)EXPERIMENTALLY3437943 administered subcutaneous (SC) to participants with normal renal function
LY3437943 (Severe Renal Impairment)EXPERIMENTALLY3437943 administered SC to participants with severe renal impairment
LY3437943 (End-Stage Renal Disease)EXPERIMENTALLY3437943 administered SC to participants with end-stage renal disease
LY3437943EXPERIMENTALEscalating doses of LY3437943 administered as an injection under the skin in healthy participants
PlaceboPLACEBO_COMPARATORMatching placebo administered as an injection under the skin in healthy participants
Interventions
NameTypeDescription
LY3437943DRUGAdministered SC
TestDEVICEUsed to administer LY3437943 SC
ReferenceDEVICEUsed to administer LY3437943 SC
[¹⁴C]-LY3437943DRUGAdministered SC.
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures * Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive * Have clinical laboratory test results, blood pressure and...

Countries:United StatesSingapore
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