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LY4515100 via SAD

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 29, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

LY4515100 via SAD · 1 trial · 1 indication

Phase 1 1
NCT07339722A Study of LY4515100 in Healthy ParticipantsHealthy
RECRUITING123 Analytics
PHASE1RECRUITING
A Study of LY4515100 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 in Parts A and B
Day 1 up to Day 30

SAEs of LY4515100

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY4515100
Day 1 through Day 11
PK: Maximum Observed Drug Concentration (Cmax) of LY4515100
Day 1 through Day 11
PK: Time of maximum observed drug concentration (tmax) of LY4515100
Day 1 through Day 11
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY4515100 of Part A (SAD)EXPERIMENTALSingle-ascending doses of LY4515100 will be given orally
LY4515100 of Part B (MAD)EXPERIMENTALMultiple-ascending doses of LY4515100 will be given orally
LY4515100 and Itraconazole of Part CEXPERIMENTALLY4515100 and Itraconazole will be given orally
LY4515100 and Metformin of Part CEXPERIMENTALLY4515100 and Metformin will be given orally
LY4515100 and Transporter Substrates or Renal Marker of Part CEXPERIMENTALLY4515100 and Transporter Substrates or Renal Marker will be given either orally or intravenously (IV)
Placebo Part APLACEBO_COMPARATORPlacebo will be given orally
Placebo Part BPLACEBO_COMPARATORPlacebo will be given orally

Interventions

NameTypeDescription
LY4515100 via SADDRUGgiven orally
LY4515100 via MADDRUGgiven orally
LY4515100DRUGgiven orally
ItraconazoleDRUGgiven orally
CaffeineDRUGgiven orally
DigoxinDRUGgiven orally
IohexolDRUGgiven IV
MetforminDRUGgiven orally
RosuvastatinDRUGgiven orally
PlaceboDRUGgiven orally
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring. * Have a body mass index within the range of 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive). * Individua...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJul 29, 2026NCT07339722Enrollment: 40 → 123
MEDIUMJul 29, 2026NCT07339722Enrollment: 40 → 123
LOWJun 23, 2026NCT07339722lastUpdatePostDate: changed
LOWJun 23, 2026NCT07339722lastUpdatePostDate: changed

Frequently asked questions about LY4515100 via SAD

What is LY4515100 used for?

LY4515100 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with an ongoing trial evaluating its effects in healthy volunteers. The drug is not yet approved and is still in the early stages of clinical research.

Who makes LY4515100?

LY4515100 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting a Phase 1 clinical trial of this investigational small molecule in healthy participants.

What phase is LY4515100 in?

LY4515100 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting healthy participants to evaluate the drug's safety and tolerability.

What clinical trials is LY4515100 in?

LY4515100 is being studied in a Phase 1 clinical trial with the identifier NCT07339722, titled "A Study of LY4515100 in Healthy Participants." This randomized, double-blind, placebo-controlled trial is recruiting 123 healthy adults in the United States.

Is LY4515100 FDA approved?

LY4515100 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial, NCT07339722, is recruiting healthy participants to study the drug, but it has not yet received regulatory approval for any use.