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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810597
• Other study ID #: 18698
• Secondary ID: I8F-MC-GPIP
• Status: Completed
• Phase: Phase 1
• Start date: April 3, 2023
• Est. completion date: July 17, 2023

Study information

• Verified date: August 1, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tirzepatide
Administered SC

Device:
• Test
Used to administer tirzepatide SC
• Reference
Used to administer tirzepatide SC

Locations

Country	Name	City	State
United States	ICON	Salt Lake City	Utah
United States	ICON Early Phase Services	San Antonio	Texas
United States	Qps-Mra, Llc	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide	PK: Cmax of Tirzepatide	Predose up to 36 days postdose
Primary	PK: Area Under the Plasma Concentration Versus Time Curve from Zero to Time t (AUC[0-t]) of Tirzepatide	PK: AUC(0-t) of Tirzepatide	Predose up to 36 days postdose
Primary	PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Tirzepatide	PK: AUC(0-8) of Tirzepatide	Predose up to 36 days postdose