This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

What Was Tested

In this phase 1 trial, researchers set out to test Mazdutide.

It employs a multicenter, randomized, double-blind, and placebo-controlled trial design.

It had three arms (groups): one (experimental), one (experimental) and 362-dose3-Placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

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 subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent;. At screening, the Body Mass Index (BMI) meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";. Able to maintain a stable diet and exercise lifestyle during the study period;.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: prepubertal subjects (tanner stage i); subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies; use of other weight-loss medications or treatments prior to screening.

How the Study Was Run

Design: randomized, sequential and double-blind.

Because people in this Mazdutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Mazdutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-08-30 with completion listed for 2025-07-22.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of adverse events and serious adverse events (time frame: up to week 20).

It also tracked 11 secondary outcomes, for example Evaluate changes in subjects' waist-to-hip ratio（combined with waistline and hips） relative to baseline, Evaluate changes in subjects' blood pressure in mmHg relative to baseline, Evaluate changes in subjects' lipid profile in mmol/L relative to baseline, Evaluate changes in subjects' glycated hemoglobin（Hemoglobin A1c,HbA1c）in % relative to baseline, Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362 and Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Mazdutide in 36 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.