A Study of Tirzepatide Concentrations at Different Injection Sites in Participants With Different Body Sizes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04050670
Collaborator
(none)
54
1
3
6.7
8.1

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 injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices
Actual Study Start Date :
Sep 13, 2019
Actual Primary Completion Date :
Apr 3, 2020
Actual Study Completion Date :
Apr 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide - Upper Arm

Tirzepatide administered subcutaneously (SC) to the upper arm of healthy participants in one of three study periods.

Drug: Tirzepatide
Tirzepatide administered SC
Other Names:
  • LY3298176
  • Experimental: Tirzepatide - Thigh

    Tirzepatide administered SC to the thigh of healthy participants in one of three study periods.

    Drug: Tirzepatide
    Tirzepatide administered SC
    Other Names:
  • LY3298176
  • Active Comparator: Tirzepatide - Abdomen

    Tirzepatide administered SC to the abdomen of healthy participants in one of three study periods.

    Drug: Tirzepatide
    Tirzepatide administered SC
    Other Names:
  • LY3298176
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [Predose through approximately Day 36 postdose]

      PK: AUC of Tirzepatide

    2. PK: Maximum Concentration (Cmax) of Tirzepatide [Predose through approximately Day 36 postdose]

      PK: Cmax 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 females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures

    • Are between the body mass index (BMI) of 18.5 and 45.0 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 gastrointestinal (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 Covance Clinical Research Inc Daytona Beach Florida United States 32117

    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:
    NCT04050670
    Other Study ID Numbers:
    • 17224
    • I8F-MC-GPHI
    First Posted:
    Aug 8, 2019
    Last Update Posted:
    Apr 22, 2020
    Last Verified:
    Apr 15, 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:

    Study Results

    No Results Posted as of Apr 22, 2020