Overview

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

Status:
Not yet recruiting
Trial end date:
2023-07-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Tirzepatide
Criteria
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