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A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05810597
Collaborator
(none)
65
Enrollment
3
Locations
2
Arms
3.6
Anticipated Duration (Months)
21.7
Patients Per Site
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Bioequivalence Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants
Actual Study Start Date :
Apr 3, 2023
Anticipated Primary Completion Date :
Jul 22, 2023
Anticipated Study Completion Date :
Jul 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide - Test

A single dose of tirzepatide administered by subcutaneous (SC) injection via a test device (test formulation)

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    • Device: Test
    Used to administer tirzepatide SC
    Active Comparator: Tirzepatide - Reference

    A single dose of tirzepatide administered by SC injection via a reference device (reference formulation)

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    • Device: Reference
    Used to administer tirzepatide SC

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide [Predose up to 36 days postdose]

      PK: Cmax of Tirzepatide

    2. PK: Area Under the Plasma Concentration Versus Time Curve from Zero to Time t (AUC[0-t]) of Tirzepatide [Predose up to 36 days postdose]

      PK: AUC(0-t) of Tirzepatide

    3. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide [Predose up to 36 days postdose]

      PK: AUC(0-∞) of Tirzepatide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures

    • Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening

    • Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study

    • Are agreeable to receiving study treatment by injections under the skin

    • Are agreeable to following study contraception requirements

    Exclusion Criteria:

    • Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

    • Smoke more than the equivalent of 10 cigarettes per day

    • Is a known user of drugs of abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qps-Mra, Llc South Miami Florida United States 33143
    2 ICON Early Phase Services San Antonio Texas United States 78209
    3 ICON Salt Lake City Utah United States 84124

    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

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05810597
    Other Study ID Numbers:
    • 18698
    • I8F-MC-GPIP
    First Posted:
    Apr 12, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Mar 1, 2023
    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:
    Yes
    Additional relevant MeSH terms:
    Tirzepatide

    Study Results

    No Results Posted as of Apr 18, 2023