A Study to Measure Food and Calorie Consumption in Very Overweight Participants Using Tirzepatide

Study Overview
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Brief Summary
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This is a study of tirzepatide in very overweight participants. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study will last 28 weeks and will include about 21 visits to the study center.

Official Title
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A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive Have a stable body weight in the past 1 month prior to screening Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Exclusion Criteria: Have undergone gastric bypass or bariatric surgery Have a diagnosis of type 2 diabetes Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening Have any lifetime history of a suicide attempt Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)

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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No

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: Tirzepatide<br>Tirzepatide administered subcutaneously (SC). | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Placebo Comparator: Placebo<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 18 in Sleep Metabolic Rate (SMR) | Change from Baseline to Week 18 in SMR | Baseline, Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 18 in Food Intake During Ad Libitum Meal | Change from Baseline to Week 18 in Food Intake During Ad Libitum Meal | Baseline, Week 18 | 
| Change from Baseline to Week 18 in 24-hour Energy Expenditure (EE) | Change from Baseline to Week 18 in 24-hour EE | Baseline, Week 18 | 
| Change from Baseline to Week 18 in 24 Hour Respiratory Quotient | Change from Baseline to Week 18 in 24 Hour Respiratory Quotient | Baseline, Week 18 | 
| Change from Baseline to Week 18 in Percentage of Body Fat Mass | Change from Baseline to Week 18 in Percentage of Body Fat Mass | Baseline, Week 18 | 
| Change from Baseline to Week 18 in Free Fatty Acids | Change from Baseline to Week 18 in Free Fatty Acids | Baseline, Week 18 during standardized mixed meal tolerance test | 
| Change from Baseline to Week 18 in Fasting Insulin Resistance | Fasting insulin resistance measured using the Homeostatic Model of Assessment method | Baseline, Week 18 during standardized mixed meal tolerance test | 
| Change from Baseline to Week 18 in Postmeal Glucose | Change from Baseline to Week 18 in Postmeal Glucose | Baseline, Week 18 during standardized mixed meal tolerance test |