A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Tirzepatide.

The main purpose of this study is to learn more about the safety and side effects of tirzepatide in Chinese participants with type 2 diabetes mellitus.

The study will also measure how much tirzepatide gets into the bloodstream and how long it takes the body to remove it.

The study will last about six or eight months for each participant.

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

Participants received placebo once weekly (QW) subcutaneously (SC).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 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 a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²), inclusive.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to visit 1; have known allergies to tirzepatide, glp-1 analogs, or related compounds or any components of the formulation.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 2020-10-21 with completion listed for 2021-08-17.

It ran at 2 sites in China (2).

Its stated primary purpose is basic science.

What Was 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 up to 43 Weeks).

It also tracked 4 secondary outcomes, for example PK: AUC [0-168] of Tirzepatide (Cohort 2), PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1) and PK: Cmax of Tirzepatide (Cohort 2).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 24 people.

Its size is small, so on its own it can only give an early look.

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.