Clinical Study of IBI362 in Healthy Chinese Male Subjects

What Was Tested

The trial (phase 1) is built around Mazdutide.

It had two arms (groups): IBI362 liquid formulation (experimental) and IBI362 lyophilized powder (experimental).

Participants received single subcutaneous injection of IBI362 liquid formulation.

Participants received single subcutaneous injection of IBI362 lyophilized powder.

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to men only aged from 20 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 20 years old≤ Healthy males≤45 years old. 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m². Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: subjects who have previously completed or discontinued from this study, or who have used ibi362; abnormal vital signs and physical examination during the screening period;; have a previous or current mental illness.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Mazdutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-03-03 with completion listed for 2021-03-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Evaluate the PK parameters of IBI362 in healthy Chinese male subjects. Evaluate the PK parameters of IBI362 in healthy Chinese male subjects.

It also tracked 1 secondary outcome, for example Number of Participants With Adverse Events.

What This Means in Plain Language

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

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

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.