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A Study of IBI362 [amount hidden] in Chinese Adults With Obesity
Plain-language guide to NCT06164873: phase 3 randomized trial of Mazdutide, 462 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06164873
- Phase
- phase 3
- Status
- status unknown
- Start
- 2023-12-27
- Completion (planned or actual)
- 2025-06-27
- Participants
- 462 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obesity
- 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.
All study treatment will be administered once-weekly and subcutaneously.
It had two arms (groups): Placebo (placebo comparator) and IBI362 (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 462 actual participants took part.
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: Male or female, age 18 years or older at the time of signing informed consent. Have a BMI ≥30 kg/m2. Have a history of at least one self-reported unsuccessful dietary effort to lose body weight. Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening.
The full record lists 7 inclusion and 2 exclusion criteria; among the exclusions: have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment; have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
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 participants stayed in one arm throughout.
Neither the participants nor the staff measuring them knew who was on Mazdutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2023-12-27 with completion listed for 2025-06-27.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percent Change from Baseline in Body Weight (time frame: Week 60).
It also tracked 8 secondary outcomes, for example Change from Baseline in Waist Circumference, Change from Baseline in Systolic Blood Pressure, Percent Change from Baseline in Triglycerides, Percent Change from Baseline in non-high-density lipoprotein cholesteroal and Percent Change from Baseline in low-density lipoprotein cholesterol.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Mazdutide in 462 people.
Its status is unknown; 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.