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A Study of Tirzepatide in Overweight and Very Overweight Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04311411
Collaborator
(none)
111
Enrollment
3
Locations
3
Arms
29.2
Anticipated Duration (Months)
37
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
111 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Tirzepatide and placebo dosing are double-blind. Liraglutide dosing is open label.
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Aug 24, 2020
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC).

Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    Placebo administered SC.

    Drug: Placebo
    Administered SC.
    Active Comparator: Liraglutide

    Liraglutide administered SC.

    Drug: Liraglutide
    Administered SC.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Energy Intake (kilocalories per day) [Baseline, Week 3]

      Energy intake (kcal/day) will be assessed by ad libitum food intake test

    Secondary Outcome Measures

    1. 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 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

    2. Change from Baseline in Fasting and Postprandial Appetite Visual Analog Scale (VAS) [Baseline, Week 3]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University School of Medicine Indianapolis Indiana United States 46202
    2 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808
    3 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04311411
    Other Study ID Numbers:
    • 17223
    • I8F-MC-GPHH
    First Posted:
    Mar 17, 2020
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Overweight
    Liraglutide
    Tirzepatide

    Study Results

    No Results Posted as of Aug 10, 2022