A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Semaglutide.

It had two arms (groups): GZR18 (experimental) and Semaglutide (active comparator).

GZR18 injection s.c.

Semaglutide injection s.c.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 272 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: (1) Chinese adults, male or female aged between 18 and 75 (including both ends).

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: (1) known or suspected to be allergic to glp-1 drugs or their excipients, or have contraindications to their use.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2023-08-09 with completion listed for 2024-07-20.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks (time frame: 24 weeks).

It also tracked 2 secondary outcomes, for example The overall incidence of adverse events and the incidence of serious adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 272 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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