A Study of Tirzepatide in Overweight and Very Overweight Participants

Phase 1

Completed

• Conditions: Obesity; Overweight
• Interventions: Drug: Placebo; Drug: Tirzepatide; Drug: Liraglutide

• Registration Number: NCT04311411
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2020-08-24
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Results First Submitted: 2023-12-12
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Results First Posted: 2024-05-22
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo administered into the SC tissue of the abdominal wall.
Tirzepatide	Tirzepatide	Participants received tirzepatide 5 milligrams (mg) once a week (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the subcutaneous (SC) tissue of the abdominal wall.
Liraglutide	Liraglutide	Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3	Baseline, Week 3	Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States