search
Back to results

A Study of Tirzepatide in Overweight and Very Overweight Participants

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Liraglutide
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University School of Medicine
  • Pennington Biomedical Research Center
  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Tirzepatide

Placebo

Liraglutide

Arm Description

Tirzepatide administered subcutaneously (SC).

Placebo administered SC.

Liraglutide administered SC.

Outcomes

Primary Outcome Measures

Change from Baseline in Energy Intake (kilocalories per day)
Energy intake (kcal/day) will be assessed by ad libitum food intake test

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 16, 2020
Last Updated
February 23, 2023
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT04311411
Brief Title
A Study of Tirzepatide in Overweight and Very Overweight Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Tirzepatide and placebo dosing are double-blind. Liraglutide dosing is open label.
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Tirzepatide administered subcutaneously (SC).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Arm Title
Liraglutide
Arm Type
Active Comparator
Arm Description
Liraglutide administered SC.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
Change from Baseline in Energy Intake (kilocalories per day)
Description
Energy intake (kcal/day) will be assessed by ad libitum food intake test
Time Frame
Baseline, Week 3
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Baseline, Week 3
Title
Change from Baseline in Fasting and Postprandial Appetite Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline, Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3lm77tQ6Zi4YpYUnGE0fDr
Description
A Study of Tirzepatide in Overweight and Very Overweight Participants

Learn more about this trial

A Study of Tirzepatide in Overweight and Very Overweight Participants

We'll reach out to this number within 24 hrs