A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

Study Overview
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Brief Summary
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The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes. The study will last about 13 weeks for each participant, including screening.

Official Title
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The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

Conditions
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Overweight, Obesity, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Key Exclusion Criteria Have undergone gastric bypass or bariatric surgery Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months Have any lifetime history of a suicide attempt Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study Unwilling to comply with smoking and alcohol restrictions 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide + Acetaminophen<br>Tirzepatide administered subcutaneously (SC) and acetaminophen administered orally. | Drug: Tirzepatide<br>* Tirzepatide administered SC.<br>* Other names: LY3298176;Drug: Acetaminophen<br>* Acetaminophen administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Time of Maximum Concentration (Tmax) of Acetaminophen | PK: Tmax of Acetaminophen | Pre-dose through 36 hours post-dose on Day-1 | 
| PK: Tmax of Acetaminophen | PK: Tmax of Acetaminophen | Pre-dose through 36 hours post-dose on Day 2 | 
| PK: Tmax of Acetaminophen | PK: Tmax of Acetaminophen | Pre-dose through 36 hours post-dose on Day 37 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Change from Baseline in HbA1c | Pre-dose through 9 weeks | 
| PK: AUC(0-tlast) of Tirzepatide at Steady State | PK: AUC(0-tlast) of Tirzepatide at Steady State | Pre-dose through 9 weeks | 
| PK: Cmax of Tirzepatide at Steady State | PK: Cmax of Tirzepatide at Steady State | Pre-dose through 9 weeks |