A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.

Official Title
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A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants

Conditions
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Healthy, Obese

Intervention / Treatment
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* Drug: LY3502970


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants who are overtly healthy as determined by medical evaluation Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more Participants with a stable body weight, with 5% or less body weight gain or loss Exclusion Criteria: Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL) Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome Have known clinically significant gastric emptying abnormality Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass) Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3502970 (Part A)<br>The multiple doses of LY3502970 administered orally either in tablet or capsule formulations. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (Part B)<br>The multiple doses of LY3502970 administered orally in tablet formulation. | Drug: LY3502970<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 | PK: AUC[0-24] of LY3502970 | Predose up to 92 days postdose | 
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose up to 92 days postdose | 
| PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 | PK: Tmax of LY3502970 | Predose up to 92 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: AUC[0-24] of LY3502970 in fed state | PK: AUC[0-24] of LY3502970 in fed state | Predose up to 92 days postdose | 
| PK: Cmax of LY3502970 in fed state | PK: Cmax of LY3502970 in fed state | Predose up to 92 days postdose | 
| PK: Tmax of LY3502970 in fed state | PK: Tmax of LY3502970 in fed state | Predose up to 92 days postdose |