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LY5625575

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Sep 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment204

FDA Designations

No designations recorded

Clinical trial landscape

LY5625575 · 1 trial · 2 indications

Phase 1 1
NCT07801300A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)Healthy Volunteers
NOT YET_RECRUITING204 Analytics
PHASE1NOT YET_RECRUITING
A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to Day 24

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

Secondary Endpoints

Pharmacokinetics (PK): Area under the Concentration Versus Time Curve (AUC) of LY5625575
Day 1 Predose up to Day 17
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY5625575 (Part A) - Single Dose HealthyEXPERIMENTALSingle escalating doses of LY5625575 administered orally in healthy participants.
Placebo (Part A) - Single Dose HealthyPLACEBO_COMPARATORSingle dose of placebo administered orally in healthy participants.
LY5625575 (Part B) - Multiple Dose HealthyEXPERIMENTALTwo or more doses of LY5625575 administered orally in healthy participants.
Placebo (Part B) - Multiple Dose HealthyPLACEBO_COMPARATORTwo or more doses of placebo administered orally in healthy participants.
LY5625575 (Part C) - Multiple Dose Elevated hsCRPEXPERIMENTALTwo or more doses of LY5625575 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP).
Placebo (Part C) - Multiple Dose Elevated hsCRPPLACEBO_COMPARATORTwo or more doses of placebo administered orally in participants with elevated hsCRP.
LY5625575 (Part D) - Multiple Dose Healthy JapaneseEXPERIMENTALTwo or more doses of LY5625575 administered orally in healthy Japanese participants.
Placebo (Part D) - Multiple Dose Healthy JapanesePLACEBO_COMPARATORTwo or more doses of placebo administered orally in healthy Japanese participants
LY5625575 (Part E) - Multiple Dose Healthy ChineseEXPERIMENTALTwo or more doses of LY5625575 administered orally in healthy Chinese participants.
Placebo (Part E) - Multiple Dose Healthy ChinesePLACEBO_COMPARATORTwo or more doses of placebo administered orally in healthy Chinese participants.

Interventions

NameTypeDescription
LY5625575DRUGAdministered orally.
PlaceboDRUGAdministered orally.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * All Parts: * Individuals not of childbearing potential may participate in this trial. * Individuals assigned male at birth may participate in this trial. * Healthy as defined by * the absence of clinically significant illness and surgery within 35 days prior to fir...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07801300NEW_TRIAL: changed
LOWSep 3, 2026NCT07801300NEW_TRIAL: changed