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A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Plain-language guide to NCT07255209: phase 3 randomized trial of Mazdutide, 180 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07255209
Phase
phase 3
Status
recruiting participants
Start
2025-12-29
Completion (planned or actual)
2027-10-31
Participants
180 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Adolescents With Obesity or Overweight With Weight-Related Comorbidities
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Mazdutide.

It had three arms (groups): Placebo (placebo comparator), IBI362-dose2 (experimental) and IBI362-dose1 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 180 planned participants were the target.

It was open to people of any sex aged from 12 years up to 18 years.

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

Examples of who could join: Male or female participants aged ≥12 years and \<18 years at the time of signing the informed consent/assent form. Weight change \<5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: prior diagnosis of type 1 diabetes; pre-pubertal participants (tanner stage i); history of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed \>1 year before screening).

How the Study Was Run

Design: randomized, sequential and double-blind.

Random assignment meant chance, not the researchers, decided who got Mazdutide and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant and investigator.

It started in 2025-12-29 with completion listed for 2027-10-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline in BMI (time frame: Week 32).

It also tracked 3 secondary outcomes, for example Percent Change from Baseline in BMI.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide in 180 people.

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

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

Our Notes on the Compound

Mazdutide: A dual GLP-1 and glucagon receptor agonist with approvals announced in China for weight management and type 2 diabetes.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.