A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Tirzepatide.

The study will last about 16 weeks (total), including screening and follow-up.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants received placebo administered into the SC tissue of the abdominal wall.

The registry classes the interventions as drug.

Who Took Part

The registry lists 48 actual participants took part.

It was open to people of any sex aged from 20 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase \[DPP\]-IV inhibitors). Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: have known allergies to tirzepatide, glucagon-like peptide (glp)-1 analogs, or related compounds.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

The Tirzepatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-11-15 with completion listed for 2018-05-29.

It ran at 2 sites in Japan (2).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 85).

It also tracked 3 secondary outcomes, for example PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 48 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.