A Study of IBI362 in Participants With Obesity or Overweight

What Was Tested

This registered phase 3 trial tested Mazdutide.

The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

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

Placebo,SC,once a week for 48 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 610 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.

The full record lists 0 inclusion and 7 exclusion criteria; among the exclusions: have used or are currently using weight loss drugs within 3 months before screening;; history of pancreatitis;; family or personal history of thyroid c-cell carcinoma or multiple endocrine neoplasia (men) 2a or 2b；.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Mazdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2022-11-14 with completion listed for 2023-08-21.

It ran at 23 sites in China (23).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change from Baseline in Body Weight (time frame: Baseline, Week 32).

It also tracked 28 secondary outcomes, for example Change from Baseline in Waist Circumference, Percent Change from Baseline in Body Weight, Change from Baseline in Neck Circumference, Change from Baseline in Hip Circumference, Change from Baseline in Body Weight and Percent Change from Baseline in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide in 610 people.

With 610 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, all human trials.