A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

What Was Tested

In this phase 3 trial, researchers set out to test Mazdutide for sleep apnea (obstructive).

All study treatment will be administered once-weekly and subcutaneously.

It had two arms (groups): placebo (placebo comparator) and IBI362 (experimental).

Participants receive placebo by subcutaneous (SC) injection once a week.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 260 planned participants were the target.

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: For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study. For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have been used for at least 4 weeks prior to screening. For all subjects:. Age ≥18 years at the time of signing informed consent. Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: are unwilling to stop pap therapy for 7 days prior to polysomnography (psg) testing during the course of the study for all subjects：; have type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm); diagnosis of obesity hypoventilation syndrome or daytime hypercapnia.

How the Study Was Run

It was run as a randomized, parallel-group and triple-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 sleep apnea (obstructive) participants and researchers unaware of who received Mazdutide.

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

It started in 2025-06-12 with completion listed for 2027-05-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline in Apnea-Hypopnea Index (AHI) (time frame: Week 48).

It also tracked 6 secondary outcomes, for example Percent Change from Baseline in Body Weight, Change from Baseline in Systolic Blood Pressure (SBP), Percent Change from Baseline in Apnea-Hypopnea Index (AHI), Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 and Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide in 260 people with sleep apnea (obstructive).

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, Sleep apnea (obstructive) research.