A Study of Tirzepatide in Overweight and Very Overweight Participants

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311411
• Other study ID #: 17223
• Secondary ID: I8F-MC-GPHH
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2020
• Est. completion date: December 16, 2022

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Tirzepatide
Administered SC.
• Placebo
Administered SC.
• Liraglutide
Administered SC.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3	Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.	Baseline, Week 3
Secondary	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	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.	Baseline, Week 3
Secondary	Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score	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.	Baseline, Week 3

External Links

•   A Study of Tirzepatide in Overweight and Very Overweight Participants