A Study of Tirzepatide in Overweight and Very Overweight Participants

Study Overview
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Brief Summary
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The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center.

Official Title
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Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Placebo
* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have stable body weight for the past 1 month prior to screening Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Women must not be pregnant or breastfeeding Exclusion Criteria: Have undergone or plan to undergo gastric bypass or bariatric surgery Have claustrophobia or have ferromagnetic implants that can interfere with completion of fMRI measurements 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 Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening Have a diagnosis of type 2 diabetes

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
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>|
| Active Comparator: Liraglutide<br>Liraglutide administered SC. | Drug: Liraglutide<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 in Energy Intake (kilocalories per day) | Energy intake (kcal/day) will be assessed by ad libitum food intake test | Baseline, Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Blood Oxygenation Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation to Images of High-Fat Foods during the Fasting State in the Brain Reward Areas | Change from Baseline in Blood Oxygenation Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation to Images of High-Fat Foods during the Fasting State in the Brain Reward Areas | Baseline, Week 3 | 
| Change from Baseline in Fasting and Postprandial Appetite Visual Analog Scale (VAS) | The VAS scales will be analyzed as continuous variables on the 0-100 scale for individual components. Overall appetite score will be calculated as the average of the four individual scores (satiety + fullness + [100-prospective food consumption] + [100-hunger]/4). The higher overall appetite score indicates less appetite and the lower score indicates more appetite. | Baseline, Week 3 |