A Study of LY3541105 in Healthy and Overweight Participants

Study Overview
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Brief Summary
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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. This is a 2-part study and may last up to 15 and 26 weeks for each participant and may include up to 7 and 15 visits in parts A and B, respectively.

Official Title
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A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants

Conditions
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Overweight, Healthy

Intervention / Treatment
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* Drug: LY3541105
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 than or equal to (>/=) 18.5 to less than (<) 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of >/=27 to <40 kg/m², both inclusive (in Part B) Have had a stable weight for the last 3 months Exclusion Criteria: Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator Have history or current evidence of a clinically significant cardiovascular condition

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3541105 (Part A)<br>Single ascending doses of LY3541105 administered subcutaneously (SC). | Drug: LY3541105<br>* Administered SC.<br>|
| Experimental: LY3541105 (Part B)<br>Multiple ascending doses of LY3541105 administered SC. | Drug: LY3541105<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Predose up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105 | PK: AUC of LY3541105 | Predose through day 43 (Part A) & day 64 (Part B) | 
| PK: Time of Maximum observed Concentration (Tmax) of LY3541105 | PK: Tmax of LY3541105 | Predose through day 43 (Part A) & day 64 (Part B) | 
| PK: Maximum Observed Concentration (Cmax) of LY3541105 | PK: Cmax of LY3541105 | Predose through day 43 (Part A) & day 64 (Part B) | 
| Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight | PD: Absolute and Percentage Change from Baseline in Body Weight | Predose through week 26 (Part B Only) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity