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A Study to Measure Food and Calorie Consumption in Very Overweight Participants Using Tirzepatide

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04081337
Collaborator
(none)
55
Enrollment
1
Location
2
Arms
22.5
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study of tirzepatide in very overweight participants. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study will last 28 weeks and will include about 21 visits to the study center.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects
Actual Study Start Date :
Jul 9, 2020
Actual Primary Completion Date :
May 26, 2022
Actual Study Completion Date :
May 26, 2022

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline to Week 18 in Sleep Metabolic Rate (SMR) [Baseline, Week 18]

      Change from Baseline to Week 18 in SMR

    Secondary Outcome Measures

    1. Change from Baseline to Week 18 in Food Intake During Ad Libitum Meal [Baseline, Week 18]

      Change from Baseline to Week 18 in Food Intake During Ad Libitum Meal

    2. Change from Baseline to Week 18 in 24-hour Energy Expenditure (EE) [Baseline, Week 18]

      Change from Baseline to Week 18 in 24-hour EE

    3. Change from Baseline to Week 18 in 24 Hour Respiratory Quotient [Baseline, Week 18]

      Change from Baseline to Week 18 in 24 Hour Respiratory Quotient

    4. Change from Baseline to Week 18 in Percentage of Body Fat Mass [Baseline, Week 18]

      Change from Baseline to Week 18 in Percentage of Body Fat Mass

    5. Change from Baseline to Week 18 in Free Fatty Acids [Baseline, Week 18 during standardized mixed meal tolerance test]

      Change from Baseline to Week 18 in Free Fatty Acids

    6. Change from Baseline to Week 18 in Fasting Insulin Resistance [Baseline, Week 18 during standardized mixed meal tolerance test]

      Fasting insulin resistance measured using the Homeostatic Model of Assessment method

    7. Change from Baseline to Week 18 in Postmeal Glucose [Baseline, Week 18 during standardized mixed meal tolerance test]

      Change from Baseline to Week 18 in Postmeal Glucose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive

    • Have a stable body weight in the past 1 month prior to screening

    • Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

    Exclusion Criteria:

    • Have undergone gastric bypass or bariatric surgery

    • Have a diagnosis of type 2 diabetes

    • Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data

    • Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening

    • Have any lifetime history of a suicide attempt

    • Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening

    • Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    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:
    NCT04081337
    Other Study ID Numbers:
    • 17092
    • I8F-MC-GPGU
    First Posted:
    Sep 9, 2019
    Last Update Posted:
    Aug 2, 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:
    Tirzepatide

    Study Results

    No Results Posted as of Aug 2, 2022