The Phase 3 clinical trial for Mazdutide (also known as IBI362), investigating its use in Chinese adults with obesity, reached its primary completion on 2025-06-27. This significant milestone for study NCT06164873 indicates that the main treatment and data collection phase for the primary endpoints has concluded, moving the drug closer to potential data analysis and reporting.

Background

Mazdutide is currently under investigation as a therapeutic agent for obesity. This specific trial focuses on evaluating its efficacy and safety profile within the Chinese adult population, addressing a significant public health concern.

Trial design

Designated as NCT06164873, this is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study. The trial enrolled a total of 462 participants, all of whom are Chinese adults diagnosed with obesity. Participants were randomly assigned to one of two groups: receiving either IBI362 9 mg or a placebo. The study treatment involves once-weekly subcutaneous administration. The entire trial cycle is structured to include a 2-week screening period, followed by a 60-week double-blind treatment period, and concluding with a 12-week drug withdrawal follow-up period after the cessation of treatment. The primary objective is to evaluate the efficacy and safety of IBI362 9 mg in this patient cohort.

What this means

The primary completion of this Phase 3 trial signifies a critical step in the development of Mazdutide. It means that all enrolled participants have completed the designated treatment and observation period for the study's primary objectives. The next phase involves comprehensive data analysis to determine the efficacy and safety profile of Mazdutide 9 mg compared to placebo. The outcomes of this analysis will be pivotal for informing future regulatory submissions and establishing Mazdutide's potential role as a treatment for obesity in Chinese adults.

Source

The information regarding the primary completion of the Mazdutide trial was sourced from ClinicalTrials.gov, a widely recognized public database for clinical studies. The update for study NCT06164873, titled 'A Study of IBI362 9 mg in Chinese Adults With Obesity,' was officially recorded on 2025-06-27 on clinicaltrials.gov.