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LY3985297

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Sep 11, 2025

LY3985297 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

LY3985297 clinical trials

LY3985297 · 1 trial · 1 indication

Phase 1 1
NCT06395012A First-In-Human Study of LY3985297 in Healthy ParticipantsHealthy
COMPLETED140 Analytics
PHASE1COMPLETED
A First-In-Human Study of LY3985297 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of participants with one or more Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Baseline up to Week 13 (Part A), Week 17 (Part B)

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

Secondary Endpoints

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3985297 following intravenous (IV) administration
Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
PK: Cmax of LY3985297 following subcutaneous (SC) administration
Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985297 following IV administration
Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: LY3985297 (Cohorts 1-8)EXPERIMENTALSingle ascending dose of LY3985297 administered either intravenously (IV) or subcutaneously (SC). Cohort 5,6 and 7 is conducted in Japanese or Chinese participants.
Part B: LY3985297 (Cohorts 1-4)EXPERIMENTALMultiple ascending dose of LY3985297 administered either IV or SC.
Placebo Comparator: Part A and B: PlaceboPLACEBO_COMPARATORPlacebo administered either IV or SC.

Interventions

NameTypeDescription
LY3985297DRUGAdministered either IV or SC.
PlaceboDRUGAdministered either IV or SC.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants must be overtly healthy, as determined by medical evaluation. * Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, and a minimum body weight of 45.0 kg. * Participants must be assigned male or female at birth and not of childbear...

Countries:United States
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Frequently asked questions about LY3985297

What is LY3985297?

LY3985297 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a first-in-human Phase 1 trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed, so its therapeutic use is not publicly defined at this stage.

Who makes LY3985297?

LY3985297 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating this investigational small molecule.

What phase is LY3985297 in?

LY3985297 is in Phase 1 clinical development. Its only recorded trial, a first-in-human study in healthy participants, has been completed. The drug is investigational and is not approved by the FDA for any indication.

What clinical trials is LY3985297 in?

LY3985297 has been evaluated in one clinical trial, NCT06395012, titled A First-In-Human Study of LY3985297 in Healthy Participants. The Phase 1 trial enrolled 140 participants in the United States, was randomized, double-blind, and placebo-controlled, and is now completed.

What does LY3985297 target?

The molecular target of LY3985297 has not been disclosed. It is described as a small molecule, but no target or target class information is publicly available, so its mechanism of action cannot be stated.

Is LY3985297 FDA approved?

No. LY3985297 is an investigational drug in Phase 1 development and has not been approved by the FDA. Its only completed trial was a first-in-human study in healthy volunteers, which is an early stage of clinical testing.