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A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04004988
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
3.9
Actual Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by an Autoinjector Versus Prefilled Syringe in Healthy Subjects
Actual Study Start Date :
Aug 19, 2019
Actual Primary Completion Date :
Dec 16, 2019
Actual Study Completion Date :
Dec 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide Test

Tirzepatide administered subcutaneously (SC) to healthy participants via an autoinjector (AI) in one of two study periods.

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    • Device: Auto-injector (AI)
    AI used to administer tirzepatide
    Experimental: Tirzepatide Reference

    Tirzepatide administered SC to healthy participants via a prefilled syringe (PFS) in one of two study periods.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    • Device: Prefilled syringe (PFS)
    PFS used to administer tirzepatide

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [Predose through approximately 35 days postdose]

      PK: AUC of Tirzepatide

    2. PK: Maximum Concentration (Cmax) of Tirzepatide [Predose through approximately 35 days postdose]

      PK: Cmax of Tirzepatide

    Eligibility Criteria

    Criteria

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

    • Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures

    • Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening

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

    Exclusion Criteria:

    • Have known allergies to tirzepatide or related compounds

    • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2

    • Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

    • Have a prior history of malignant disease(s) in the past 5 years prior to screening

    • 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 Lilly Nus Centre for Clin Pharmacology Singapore Singapore 138623

    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:
    NCT04004988
    Other Study ID Numbers:
    • 17105
    • I8F-MC-GPGS
    First Posted:
    Jul 2, 2019
    Last Update Posted:
    Jan 3, 2020
    Last Verified:
    Jan 1, 2020
    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 Jan 3, 2020