A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

It had three arms (groups): one (experimental), one (experimental) and semaglutide (active comparator).

Participants will receive GZR18 subcutaneously (SC).

Participants will receive GZR18 subcutaneously (SC).

Participants will receive semaglutide subcutaneously (SC).

The registry classes the interventions as drug.

Who Took Part

1100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Antidiabetic drugs that meet any of the following within 8 weeks before screening:.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: type 1 diabetes mellitus or special type of diabetes mellitus; diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization; severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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 2025-02-13 with completion listed for 2026-12-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline in Hemoglobin A1c (HbA1c)(%) (time frame: Baseline, Week 44).

It also tracked 6 secondary outcomes, for example Change from baseline in mean 7-point self-measured blood glucose (SMBG), Proportion of subjects with salvage therapy, Change from baseline in weight (kg), Percent change in weight from baseline (%) and Treatment emergent adverse events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1100 people.

With 1100 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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