A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

What Was Tested

This registered phase 2 trial tested Mazdutide for fat loss, obesity & body recomposition.

This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects.

This study is divided into the first stage and the second stage.

The participant enrollment and data analysis in the two stage are independent and do not influence each other.

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

Placebo administered subcutaneously (SC) once a week.

The registry classes the interventions as drug and other.

Who Took Part

328 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: diabetes mellitus; have used or are currently using weight loss drugs within 3 months before screening; history of pancreatitis.

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.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant and investigator.

It started in 2021-06-08 with completion listed for 2023-03-29.

It ran at 1 site in China.

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 24).

It also tracked 15 secondary outcomes, for example Absolute change from Baseline in body weight, Change from Baseline in Waist Circumference, Change from Baseline in BMI, Change from Baseline in HbA1c, Change from Baseline in fasting plasma glucose and Change from Baseline in systolic blood pressure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Mazdutide in 328 people with fat loss, obesity & body recomposition.

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

More context: the Mazdutide compound page, Fat loss, obesity & body recomposition research.