A Study of LY3502970 in Healthy Participants

Study Overview
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Brief Summary
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The main purposes of this study are to determine: The safety of LY3502970 and any side effects that might be associated with it. How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it. This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.

Official Title
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A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3502970
* Drug: Placebo
* Drug: Atorvastatin
* Drug: Simvastatin
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or females, as determined by medical history Have safety laboratory results within normal reference ranges Exclusion Criteria: Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds Abnormal electrocardiogram (ECG) at screening Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

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
Interventional Model Description: Part C is a crossover design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3502970 (Part A)<br>Single dose of LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br>Single dose of placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: LY3502970 (Part B)<br>Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally. | Drug: LY3502970<br>* Administered orally.<br>Drug: Atorvastatin<br>* Administered orally.<br>Drug: Simvastatin<br>* Administered orally.<br>Drug: Midazolam<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part B)<br>Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally. | Drug: Placebo<br>* Administered orally.<br>Drug: Atorvastatin<br>* Administered orally.<br>Drug: Simvastatin<br>* Administered orally.<br>Drug: Midazolam<br>* Administered orally.<br>|
| Experimental: LY3502970 (Part C)<br>Single dose of LY3502970 administered orally in each of two study periods. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (Part D)<br>Single dose of LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part D)<br>Single dose of placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: LY3502970 Formulation 1 (Part E)<br>Multiple doses of LY3502970 - formulation 1 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 Formulation 2 (Part E)<br>Multiple doses of LY3502970 - formulation 2 administered orally. | Drug: LY3502970<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 | 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 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose up to 96 hours postdose | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 | PK: AUC(0-tlast) of LY3502970 | Predose up to 96 hours postdose | 
| PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 | PK: Tmax of LY3502970 | Predose up to 96 hours postdose |