A Study of LY3478045 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 LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last 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 LY3478045in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3478045
* Drug: Placebo
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy participants as determined through medical history and physical examination Have a body mass index 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 3 months prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the 3 months prior to screening and enrollment Have safety laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged as not clinically significant by the investigator Exclusion Criteria: Have a history of fructosuria 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 (QT) data analysis Have blood pressure 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 Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: LY3478045 (Part A)<br>LY3478045 administered orally. | Drug: LY3478045<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: LY3478045 (Part B)<br>LY3478045 administered orally. | Drug: LY3478045<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered orally | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: LY3478045 + Atorvastatin (Part B)<br>LY3478045 co-administered with atorvastatin orally. | Drug: LY3478045<br>* Administered orally.<br>Drug: Atorvastatin<br>* Administered orally.<br>|
| Placebo Comparator: Placebo + Atorvastatin<br>Placebo co-administered with atorvastatin orally. | Drug: Placebo<br>* Administered orally.<br>Drug: Atorvastatin<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 up to final follow-up at approximately Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3478045 | PK: AUC(0-inf) of LY3478045 | Baseline up to final follow-up at approximately Day 28 | 
| PK: Maximum Concentration (Cmax) of LY3478045 | PK: Cmax of LY3478045 | Baseline through final follow-up at approximately Day 28 |