A Study of LY3556050 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.

Official Title
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Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3556050
* Drug: Placebo
* Drug: Iohexol
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females of nonchild bearing potential, as determined by medical history Have safety laboratory results within normal references ranges Weight at least 50 kilograms (kg) Exclusion Criteria: Have known allergies to LY3556050, iodine, metformin and related compounds Abnormal electrocardiogram (ECG) or blood pressure at screening Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders Show evidence of active renal disease with estimated glomerular filtration rate (GFR) <90 milliliters per minute per 1.73 meters squared

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
Interventional Model Description: Part A - Parallel design. Part B - Open label design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3556050 (Part A)<br>LY3556050 administered orally. | Drug: LY3556050<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|
| Other: Iohexol (Part B)<br>Iohexol given intravenously (IV). (Part B is optional.) | Drug: Iohexol<br>* Administered IV.<br>|
| Other: Metformin (Part B)<br>Metformin given orally. (Part B is optional.) | Drug: Metformin<br>* Administered orally.<br>|
| Experimental: LY3556050+ Iohexol (Part B)<br>Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.) | Drug: LY3556050<br>* Administered orally.<br>Drug: Iohexol<br>* Administered IV.<br>|
| Experimental: LY3556050 + Metformin (Part B)<br>Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.) | Drug: LY3556050<br>* Administered orally.<br>Drug: Metformin<br>* Administered orally.<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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Final Follow-up (up to Week 9)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050 | PK: Cmax of LY3556050 | Baseline through Day 17 | 
| PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) | PK: AUCτ of LY3556050 | Baseline through Day 17 |