Skip to main content
OpenTrials
Completed

NCT Number: NCT05810597

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qps-Mra, Llc, South Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Single Dose Pen

Device

Used to administer tirzepatide SC

Multi-use Prefilled Pen

Device

Used to administer tirzepatide SC

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide

    Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

    PK: Cmax of Tirzepatide

  2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide

    Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

    PK: AUC(0-t) of Tirzepatide

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

    Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

    PK: AUC(0-∞) of Tirzepatide

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.