A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04407234
Collaborator
(none)
36
1
1
3.7
9.6

Study Details

Study Description

Brief Summary

The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes.

The study will last about 13 weeks for each participant, including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date :
Sep 15, 2020
Actual Primary Completion Date :
Jan 7, 2021
Actual Study Completion Date :
Jan 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide + Acetaminophen

Tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.

Drug: Tirzepatide
Tirzepatide administered SC.
Other Names:
  • LY3298176
  • Drug: Acetaminophen
    Acetaminophen administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Time of Maximum Concentration (Tmax) of Acetaminophen [Pre-dose through 36 hours post-dose on Day-1]

      PK: Tmax of Acetaminophen

    2. PK: Tmax of Acetaminophen [Pre-dose through 36 hours post-dose on Day 2]

      PK: Tmax of Acetaminophen

    3. PK: Tmax of Acetaminophen [Pre-dose through 36 hours post-dose on Day 37]

      PK: Tmax of Acetaminophen

    Secondary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Pre-dose through 9 weeks]

      Change from Baseline in HbA1c

    2. PK: AUC(0-tlast) of Tirzepatide at Steady State [Pre-dose through 9 weeks]

      PK: AUC(0-tlast) of Tirzepatide at Steady State

    3. PK: Cmax of Tirzepatide at Steady State [Pre-dose through 9 weeks]

      PK: Cmax of Tirzepatide at Steady State

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening

    • For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening

    • For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months

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

    Key Exclusion Criteria

    • Have undergone gastric bypass or bariatric surgery

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

    • For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months

    • Have any lifetime history of a suicide attempt

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Pharmacology of Miami Hialeah Florida United States 33014

    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:
    NCT04407234
    Other Study ID Numbers:
    • 17376
    • I8F-MC-GPHU
    First Posted:
    May 29, 2020
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Jan 1, 2021
    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:

    Study Results

    No Results Posted as of Jan 20, 2021