A Study of Tirzepatide (LY3298176) in Healthy Participants

What Was Tested

The trial (phase 1) is built around Tirzepatide.

This study has four parts.

Each participant will enroll in one part.

Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin).

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo SC-Part C (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 52 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: Overtly healthy males or females, as determined by medical history and physical examination. Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-12-19 with completion listed for 2018-12-27.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide (time frame: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose). PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide.

It also tracked 3 secondary outcomes, for example PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide, PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide and PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 52 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.