A Study of IBI362 in Participants With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Mazdutide and Dulaglutide.

This trial is conducted in China.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 731 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. Age ≥ 18 when signing the informed consent form. BMI≥23 kg/m2 at screening. 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; oral hypoglycemic drugs other than background therapy drugs have been used within 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

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

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

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

As a double-blind Mazdutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-01-06 with completion listed for 2024-01-26.

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 28 (time frame: Baseline, 28 weeks).

It also tracked 13 secondary outcomes, for example percent change from baseline in body weigh, 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) and volume distribution (V).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide and Dulaglutide in 731 people.

With 731 participants it is a large trial for this field.

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

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