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Completed

NCT Number: NCT04311411

A Study of Tirzepatide in Overweight and Very Overweight Participants

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University School of Medicine, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC.

Other names: LY3298176

Placebo

Drug

Administered SC.

liraglutide

Drug

Administered SC.

Primary outcomes

  1. Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3

    Time frame: Baseline, Week 3

    Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.

Secondary outcomes

  1. Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas

    Time frame: Baseline, Week 3

    Change from baseline in BOLD fMRI signals in response to images of highly palatable foods (high fat-high sugar and high fat-high carbohydrate) relative to nonfood items during the fasting state in the brain reward areas (Insula, medial frontal gyrus, superior temporal gyrus, precentral gyrus, and cingulate gyrus) at Week 3 is reported. fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of viewing food images in each brain reward areas was measured by the signal change in BOLD response. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) model with covariates Baseline + Treatment + Baseline Body mass index (BMI) Stratum + Scanner Identification + Week + Treatment*Week + Participant + Random Error.

  2. Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score

    Time frame: Baseline, Week 3

    The VAS determines the effects on appetite sensations and desire for specific foods. It consists of 8 individual questions that measure hunger, satiety, fullness, prospective food consumption, desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food. The VAS scales will be analyzed as continuous variables on the 0-100 scale for 8 individual components. Hunger, satiety, fullness, prospective food consumption are rated as 0=Not at all and 100=Extremely. Desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food are rated as 0=Yes, very much and 100=No, not at all. Overall appetite score is calculated as the average of the first 4 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2020
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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