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LY3540378 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 through day 113

Summary

This trial tests a new drug called LY3540378 to see if it is safe and well-tolerated. Healthy participants, including Japanese and Chinese individuals, will receive the drug over a period of time. Blood tests will show how much of the drug enters the bloodstream and how quickly it is removed from the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 through day 113
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 through day 113 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary study objectives
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3540378
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3540378

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3540378 (Part D)Experimental Treatment1 Intervention
Multiple ascending doses of LY3540378 administered SC in Chinese Participants.
Group II: LY3540378 (Part C)Experimental Treatment1 Intervention
Multiple ascending doses of LY3540378 administered SC in Japanese Participants.
Group III: LY3540378 (Part B)Experimental Treatment1 Intervention
Multiple ascending doses of LY3540378 administered SC.
Group IV: LY3540378 (Part A)Experimental Treatment1 Intervention
Single ascending doses of LY3540378 administered either intravenously (IV) or subcutaneously (SC).
Group V: Placebo (Part A, B, C & D)Placebo Group1 Intervention
Placebo administered either IV or SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3540378
2021
Completed Phase 1
~140

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,667 Previous Clinical Trials
3,228,343 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,383 Previous Clinical Trials
426,007 Total Patients Enrolled
~29 spots leftby Nov 2025
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