A Study of LY3841136 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 LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.

Official Title
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants

Conditions
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Obesity, Healthy

Intervention / Treatment
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* Drug: LY3841136
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential Have had a stable weight for the last 3 months Have a body mass index (BMI) in the range of 18.5 to 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) Exclusion Criteria: Are women who are lactating Have known allergies to related compounds of LY3841136 or any components of the formulation Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions Have been diagnosed with Type 1 or Type 2 diabetes mellitus Have a history of chronic medical conditions involving the heart, liver, or kidneys

Ages Eligible for Study
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Minimum Age: 18 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: LY3841136 (Part A)<br>Single ascending doses of LY3841136 administered subcutaneously (SC). | Drug: LY3841136<br>* Administered SC.<br>|
| Experimental: LY3841136 (Part B)<br>Multiple ascending doses of LY3841136 administered SC. | Drug: LY3841136<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 14 weeks (Part A) & 28 weeks (Part B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136 | PK: AUC of LY3841136 | Predose through week 14 (Part A) & week 28 (Part B) | 
| PK: Maximum Observed Concentration (Cmax) of LY3841136 | PK: Cmax of LY3841136 | Predose through week 14 (Part A) & week 28 (Part B) | 
| Pharmacodynamics (PD): Change From Baseline in Body Weight | PD: Change From Baseline in Body Weight | Predose through week 28 |