A Phase 1 interventional study of LY3541105 and Placebo in Overweight and Healthy, sponsored by Eli Lilly and Company. Completed at 2 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 206 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single ascending doses of LY3541105 administered subcutaneously (SC).
Drug: LY3541105
Multiple ascending doses of LY3541105 administered SC.
Drug: LY3541105
Escalating doses of LY3541105 administered SC.
Drug: LY3541105
Placebo administered SC.
Drug: Placebo
Placebo administered SC.
Drug: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC.
Administered SC.
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
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Predose up to 26 weeks
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105
PK: AUC of LY3541105
Time frame: Predose through day 43 (Part A) & day 78 (Part B)
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
PK: Tmax of LY3541105
Time frame: Predose through day 43 (Part A) & day 78 (Part B)
PK: Maximum Observed Concentration (Cmax) of LY3541105
PK: Cmax of LY3541105
Time frame: Predose through day 43 (Part A) & day 78 (Part B)
Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight
PD: Absolute and Percentage Change from Baseline in Body Weight
Time frame: Predose through week 26 (Part B Only)
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company