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

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT04050670
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 13, 2019
Status verified
Apr 2023
Primary completion
Apr 3, 2020
Completion
Apr 3, 2020

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tirzepatide - Upper Arm
    Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
  • Experimental: Tirzepatide - Thigh
    Participants received 5mg Tirzepatide by subcutaneous injection on thigh.
  • Active Comparator: Tirzepatide - Abdomen
    Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) [ Time Frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance Clinical Research IncDaytona BeachFlorida32117-

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By research site
Covance Clinical Research Inc· Daytona Beach, FL

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