A Study of LY3522348 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study in healthy participants is to learn more about the safety of LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. This study has two parts: Part A will last up to about six weeks and Part B will last up to about eight weeks for each participant.

Official Title
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A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single- and Multiple-Ascending Doses of LY3522348 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3522348
* Drug: Placebo
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy as determined through medical evaluation including medical history and physical examination Have a body mass index of greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²) Have had a stable weight for one month prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator Exclusion Criteria: Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis Have blood pressure of greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator Have a history of fructosuria Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study

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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3522348 (Part A)<br>LY3522348 administered orally. | Drug: LY3522348<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: LY3522348 (Part B)<br>LY3522348 administered orally. Some participants will also receive midazolam. | Drug: LY3522348<br>* Administered orally.<br>Drug: Midazolam<br>* Administered orally to some participants.<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered orally. Some participants will also receive midazolam. | Drug: Placebo<br>* Administered orally.<br>Drug: Midazolam<br>* Administered orally to some participants.<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 up to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3522348 | PK: AUC of LY3522348 | Part A: Day 1 and Part B: Day 1 up to 144 hours post-last dose | 
| PK: Maximum Observed Drug Concentration (Cmax) of LY3522348 | PK: Cmax of LY3522348 | Part A: Day 1 and Part B: Day 1 up to 144 hours post-last dose |