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LY3985297

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Sep 11, 2025

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

Clinical trial landscape

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 being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other. As an investigational drug, it is not yet approved and remains in clinical development.

Who makes LY3985297?

LY3985297 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule in healthy participants.

What phase is LY3985297 in?

LY3985297 is in Phase 1 clinical development. A first-in-human study of the drug in healthy participants has been completed. The drug is investigational and has not been approved by regulatory authorities. It is still in the early stages of clinical testing.

What clinical trials is LY3985297 in?

LY3985297 has one completed clinical trial, identified as NCT06395012, titled "A First-In-Human Study of LY3985297 in Healthy Participants." This Phase 1 study enrolled 140 participants in the United States. The trial was randomized, double-blind, and placebo-controlled, and it included healthy volunteers aged 18 years and older.

Is LY3985297 FDA approved?

LY3985297 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A first-in-human study in healthy participants has been completed, but the drug has not yet received regulatory approval. It remains in clinical development and is not available for commercial use.