A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

What Was Tested

This registered phase 3 trial tested Mazdutide.

This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control.

During the whole study, subjects will be required to maintain diet and exercise control.

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

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 319 actual participants took part.

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: T2D was diagnosed according to WHO standards in 1999 for at least 2 months. Age ≥ 18 when signing the informed consent form. Maintain a stable diet and exercise lifestyle during the study. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs; used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 2 months before screening; previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes.

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 Mazdutide and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant and investigator.

It started in 2023-01-06 with completion listed for 2023-10-25.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c change from baseline at week 24 (time frame: Baseline, 24 weeks).

It also tracked 10 secondary outcomes, for example Safety, Incidence and severity of adverse events and correlation with study drug;, Time to peak plasma concentration (Tmax), Time to peak plasma concentration (Cmax), area under curve (AUC), volume distribution (V) and half-life (half-life, T1/2).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide in 319 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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