Recent Updates
Recently added Catalysts

LY3541105

Phase 1

Overweight | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jun 27, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment206

FDA Designations

No designations recorded

Clinical trial landscape

LY3541105 · 1 trial · 2 indications

Phase 1 1
NCT05380323A Study of LY3541105 in Healthy and Overweight ParticipantsOverweight
COMPLETED206 Analytics
PHASE1COMPLETED
A Study of LY3541105 in Healthy and Overweight Participants
OverweightUnlock trial analytics

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
Predose up to 26 weeks

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): Area Under the Concentration Versus Time Curve (AUC) of LY3541105
Predose through day 43 (Part A) & day 78 (Part B)
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
Predose through day 43 (Part A) & day 78 (Part B)
PK: Maximum Observed Concentration (Cmax) of LY3541105
Predose through day 43 (Part A) & day 78 (Part B)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3541105 (Part A)EXPERIMENTALSingle ascending doses of LY3541105 administered subcutaneously (SC).
LY3541105 (Part B)EXPERIMENTALMultiple ascending doses of LY3541105 administered SC.
LY3541105 (Part C)EXPERIMENTALEscalating doses of LY3541105 administered SC.
Placebo (Part A)PLACEBO_COMPARATORPlacebo administered SC.
Placebo (Part B)PLACEBO_COMPARATORPlacebo administered SC.
Placebo (Part C)PLACEBO_COMPARATORPlacebo administered SC.

Interventions

NameTypeDescription
LY3541105DRUGAdministered SC.
PlaceboDRUGAdministered SC.
Unlock Study Design Details

Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation * Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential * Have a body mass index (BMI) in the range of greater t...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about LY3541105

What is LY3541105 used for?

LY3541105 is an investigational small molecule being developed for overweight. It is a metabolic therapeutic being studied in healthy and overweight participants. The drug is currently in Phase 1 clinical development and is not approved by the FDA.

Who makes LY3541105?

LY3541105 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in overweight participants.

What phase is LY3541105 in?

LY3541105 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed. The drug is investigational and has not been approved by the FDA.

What clinical trials is LY3541105 in?

LY3541105 has one completed clinical trial, NCT05380323, titled "A Study of LY3541105 in Healthy and Overweight Participants." This Phase 1 study enrolled 206 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is LY3541105 FDA approved?

LY3541105 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 study has been completed, but the drug has not yet received regulatory approval.