Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 [amount hidden] in Patients With Moderate to Severe Obesity

What Was Tested

This registered phase 1, phase 2 trial tested Tirzepatide and Mazdutide.

This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study.

It had three arms (groups): IBI362 (experimental), Placebo (placebo comparator) and Tirzepatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 98 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: 1\. The age at the time of screening is 18 to 55 years old (including both ends), male or female;. 2\. BMI≥32.5 kg/m2 during screening;.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: 1\. the investigator suspected that the subjects might be allergic to the study drug or component or have an allergic constitution;; 7\. history of other risk factors for tachycardia;.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

The Tirzepatide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2025-06-17 with completion listed for 2026-09-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The Incidence of adverse events and serious adverse events during the treatment period (time frame: week 44). The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS) (time frame: week 44). The incidence rates of Adverse Event of Special Interest (time frame: week 44).

It also tracked 15 secondary outcomes, for example The change in body weight from baseline, Immunogenicity, The change in waist circumference from baseline, Changes and percentage changes of liver fat content compared with the baseline, The change in body-mass index from baseline and The change in neck circumference from baseline.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Tirzepatide and Mazdutide in 98 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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