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

What Was Tested

The trial (phase 1) is built around Tirzepatide.

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.

It had two arms (groups): one (experimental) and Sequence 2: Tirzepatide by MUPFP / SDP (experimental).

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 65 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: smoke more than the equivalent of 10 cigarettes per day; is a known user of drugs of abuse.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Each person switched between Tirzepatide and the comparison at some point, usually with a gap in between.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-04-03 with completion listed for 2023-07-17.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: 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. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 65 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tirzepatide compound page, all human trials.